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Understanding Europe’s MDR and IVDR
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What Is A Medical Research Organization?
- Medical Research Organization
- Stage 1 Medical Device Development Services: Concepting & Feasibility
- Stage 2 Medical Device Development Services: Design Validation/Preclinical Testing
- Stage 3 Medical Device Development Services: Clinical
- Stage 4 Medical Device Development Services: Market Approval
- Stage 5 Medical Device Development Services: Post-Market
Asian Market
- Diagnostic Developers Look to EUA Submission to Combat Novel Coronavirus (COVID-19)
- Japan Issues Amended Pharmaceuticals and Medical Devices (PMD) Act
- Chinese State Drug Administration Releases ‘Notice on the Implementation of Electronic Declaration of Medical Device Registration’
- NAMSA® Launches Chinese Website to Provide Medical Device Development Resource to APAC Sponsors
- Japan’s PMDA to Raise Medical Device and IVD Registration User Fees Beginning April 2018
- CFDA Releases Technical Guidelines for the Acceptance of Overseas Clinical Trial Data of Medical Devices
- CFDA Releases “Amendments to the Regulations on the Supervision and Administration of Medical Devices” Exposure Draft
- Japan’s “Ninsho Kijun” Regulatory Approval Pathway
- New Medical Device Classification Catalog Issued by the CFDA
- Japan’s PMDA Consultation Offering: A Beneficial Resource for Streamlined Device Approval
- NAMSA Launches Japanese Website to Support Increased Demand for Medical Device Development Services
- Focus on Japan Series: Part IV - Streamlining the Quality Management System Approval Process
- China Releases Regulations for the Supervision and Administration of Medical Devices (No. 680)
- Focus on Japan Series: Part III - Registering Facilities under Foreign Manufacturer Accreditation (FMA)
- CFDA Announces “Administrative Measures on Communication with Applicants for the Technical Evaluation of Medical Device (Trial)"
- Ensuring the Confidentiality of Chinese Medical Device Manufacturers
- Focus on Japan Series: Part I - Important Factors for Medical Device Development in Japan
- Guidelines for Medical Device Development in Japan
- CFDA Issues Announcement on Medical Device Priority Approval Procedures
- CFDA Provisions for Medical Device Adverse Event Monitoring and Re-evaluation
- The Three Pathways to Medical Device Registration in Japan
- CFDA Oversea GMP Inspections
- New Marketing Application Procedure for Combination Products in Japan
- CFDA Releases Notice Regarding GSP Compliance for Medical Device Manufacturers
- Definition of “Regenerative Medical Products” in Japanese Law Has Been Revised
- CFDA is Collecting Comments on Clinical Exemption Catalogue
- The Strategy of SAKIGAKE and How It Applies to Medical Devices
- Regenerative Medicine-Related Organizations and Activities in Japan
- CFDA and NHFPC Jointly Issue Decree No. 25 The Good Clinical Practice for Medical Devices
- PMDA Submission Strategy and CRO Limitations, Part 2
- CFDA Authenticity Verification of Clinical Trial Data for Medical Device Kick Off
- Steady Growth for China's Medical Device Fast Track Process
- PMDA Submission Strategy and CRO Limitations, Part 1
- China Acceptance of Foreign Biocompatibility Reports
- Announcing Construction of New Preclinical Laboratory for Medical Device Research in Shanghai, China
- China Regulation Updates
- CFDA Regulation Creates Changes in Chinese Regulatory Landscape
- Chinese Medical Device Market Continues to Grow
- The 2014 BPMDS Kicks Off In Germany
- NAMSA China Expands Expertise and Services
- Emerging Markets Theater - Life Science Alley Conference
Chemical Characterization
- NAMSA Launches Online Biocompatibility Strategy Application to Streamline Development Efforts for Global Medical Device Manufacturers
- White Paper: Utilizing Biological Risk Assessments and Chemical Characterization to Reduce Medical Device Development Timelines
Clinical
- Japan Issues Amended Pharmaceuticals and Medical Devices (PMD) Act
- MDR Update: Draft Corrigenda Published Outlining Positive Impact to Class I Manufacturers and Up-Classification Rules
- Key Requirements of Post-Market Surveillance under IVDR
- IVDR Technical Documentation: 5 Critical Parameters of Change You Must Understand
- NAMSA® Launches Chinese Website to Provide Medical Device Development Resource to APAC Sponsors
- NAMSA® Launches Market Intelligence Report on Global Medical Device Clinical Outsourcing Trends
- NAMSA® Launches "Uniquely IVD" Development Services to Expedite in vitro Diagnostic Technology Commercialization Efforts for Global Manufacturers
- NAMSA Recognized as Leading Medical Device CRO for Second Consecutive Year by Life Science Leader
- NAMSA Introduces French Website to Provide Resource for Accelerated Medical Device Development in Europe
- NAMSA Launches Japanese Website to Support Increased Demand for Medical Device Development Services
- NAMSA Expands Medical Device Clinical and Consulting Services Presence in Minneapolis to Accommodate Growth
- Update on FDA’s Clinical Trials Program for Medical Devices
- NAMSA White Paper: Risk-Based Monitoring: Exploring the Clinical Site Experience
- PMDA Submission Strategy and CRO Limitations, Part 2
- CFDA Authenticity Verification of Clinical Trial Data for Medical Device Kick Off
- Medical Device Clinical Trials: SAE reporting requirements in Germany and Austria
- Medical Device Development: Clinical Studies, Part 2
- NAMSA Expands Service Offering Expertise Into South America
- NAMSA White Paper: Risk-Based Monitoring: Considerations for Clinical Implementation
- Medical Device Development: Clinical Studies, Part 1
- NAMSA White Paper: FDA Pre-Submission or Q-Sub Program
- NAMSA White Paper: Risk-Based Monitoring: Setting up the Structure for a Systematic Approach
- NAMSA and Fortuna Clinical Form Strategic Relationship
- NAMSA White Paper: Human Factors Studies in Medical Device Reprocessing
- NAMSA White Paper: Risk-Based Monitoring: A Cognizant Approach
- Infographic: Common Mistakes in the Medical Device Development Continuum
- NAMSA White Paper: Joining Preclinical and Clinical Development: A Practical Approach to Reducing Medical Device Timelines
- FDA Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Outside the US
- Additional Information You Should Know Before Performing a Clinical Study
- Obstacles in European Clinical Trials
- Differences and Similarities in Investigator Selection Between the US and EU
- Things to Consider When Selecting a Clinical Investigator
- Selecting a CRO for Clinical Research
- Selecting an Optimal Study Site in the EU
- China Regulation Updates
- Conducting a Clinical Study in the US
- Remote Monitoring in Clinical Testing
- Responsibilities of an Authorized Representative and US Agent
- Updating a Clinical Evaluation Report (CER)
- The Need for an Agent for Clinical Trials in the US
- The Need for an Authorized Representative for Clinical Trials in the EU
- Insights for Clinical Management
- Meet with NAMSA on the Road
- FDA Gives New IVD Guidance
- Emerging Markets Theater - Life Science Alley Conference
- Developing a European First-In-Human (FIH) Study
- Remote Training Seminars Now Offered By NAMSA
Consulting
- MDR Update: Draft Corrigenda Published Outlining Positive Impact to Class I Manufacturers and Up-Classification Rules
- Key Requirements of Post-Market Surveillance under IVDR
- IVDR Technical Documentation: 5 Critical Parameters of Change You Must Understand
- MDCG ISSUES Guidance on Summary of Safety and Clinical Performance under the Medical Device Regulation (MDR)
- Chinese State Drug Administration Releases ‘Notice on the Implementation of Electronic Declaration of Medical Device Registration’
- EU IVDR: Understanding the New QMS Requirements
- Three Essentials for Smart IVD Clinical Trial Design
- FDA CDRH: New Organizational Structure Effective May 1, 2019
- Draft Corrigenda for EU MDR and IVDR Released
- EMA Issues Q&A Regarding Impact of MDR, Article 117
- EU Issues Q&A Document to Provide Further Analysis of Potential No-Deal Brexit
- UK MHRA Releases Contingency Legislation Covering Regulation of Medical Devices in Brexit ‘No Deal’ Scenario
- EU Commission Updates Website to Provide Additional MDR and IVDR Planning Resources
- Renewal Timelines Quickly Approaching for Medical Device Directive (MDD:M5) CE Mark Certificates
- FDA Shifts 510(K) Paradigm, Announces Transformative Steps to Modernize 510(k) Program
- EU Commission & MDCG Release New MDR & IVDR Guidance Documents
- FDA CDRH Reorganization: Faster Reviews for Medical Device Manufacturers?
- Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard
- FDA Announces FY19 User Fees
- EU Commission Issues Supplementary Guidance Information for CE Marks Under MDR & IVDR
- NAMSA® Launches "Uniquely IVD" Development Services to Expedite in vitro Diagnostic Technology Commercialization Efforts for Global Manufacturers
- Mid-Year FDA Regulation & Guidance Review
- FDA Issues New Draft Guidance Document for Pre-Submissions
- EU MDR and IVDR Compliance Planning Resources
- NAMSA Recognized as Leading Medical Device CRO for Second Consecutive Year by Life Science Leader
- CE Marking of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR
- Japan’s PMDA to Raise Medical Device and IVD Registration User Fees Beginning April 2018
- NAMSA Introduces French Website to Provide Resource for Accelerated Medical Device Development in Europe
- EU Commission Issues “Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products”
- Obtaining Actionable FDA Feedback: How to Develop Targeted Questions for Pre-Submission Meetings
- ISO 13485:2016 - Effective Preparation and Implementation of Medical Device Quality Management Systems
- Japan’s “Ninsho Kijun” Regulatory Approval Pathway
- Japan’s PMDA Consultation Offering: A Beneficial Resource for Streamlined Device Approval
- NAMSA Launches Japanese Website to Support Increased Demand for Medical Device Development Services
- Focus on Japan Series: Part IV - Streamlining the Quality Management System Approval Process
- Focus on Japan Series: Part III - Registering Facilities under Foreign Manufacturer Accreditation (FMA)
- Focus on Japan Series: Part II - Understanding the Designated Marketing Authorization (D-MAH) Status for Foreign Device Manufacturers
- NAMSA Expands Medical Device Clinical and Consulting Services Presence in Minneapolis to Accommodate Growth
- FDA Warning Letters for Non-US Manufacturers
- FDA Factors to Consider Regarding Benefit - Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions
- New Marketing Application Procedure for Combination Products in Japan
- CFDA Releases Notice Regarding GSP Compliance for Medical Device Manufacturers
- The New European MDR – Harmonization Effort with International Regulatory Requirements for Medical Devices
- FDA Finalizes Biocompatibility Guidance for Medical Devices
- FDA Issues ‘Leap-Frog’ Guidance for 3D-Printed Medical Devices
- CFDA is Collecting Comments on Clinical Exemption Catalogue
- Human Factors / Usability Engineering in Product Design and Development
- Is 2016 The Year That CMS Starts Fining Sunshine Act Violators?
- Unannounced Notified Body Audit
- FDA Clarifies Policy for Color Additives in Medical Devices
- Regenerative Medicine-Related Organizations and Activities in Japan
- CFDA and NHFPC Jointly Issue Decree No. 25 The Good Clinical Practice for Medical Devices
- PMDA Submission Strategy and CRO Limitations, Part 2
- CFDA Authenticity Verification of Clinical Trial Data for Medical Device Kick Off
- ISO 13485:2016 - Medical devices – Quality management systems – Requirements for regulatory purposes
- The Importance of Applying Human Factors and Usability Engineering to Medical Devices
- Steady Growth for China's Medical Device Fast Track Process
- PMDA Submission Strategy and CRO Limitations, Part 1
- Regulatory
  - European Commission Mandate for EU Parliament Negotiations on MDR delay: Clarification regarding Article 120(3)
  - EU Response to COVID-19 Pandemic: Proposal to Delay Date of MDR Application to May 2021 for Certain Provisions
  - FDA Releases Final Guidance on Bone Anchor Premarket Notification (510(k)) Submissions
  - U.S. FDA Announces eSTAR Pilot Program to Streamline 510(k) Submission Process
  - Diagnostic Developers Look to EUA Submission to Combat Novel Coronavirus (COVID-19)
  - Japan Issues Amended Pharmaceuticals and Medical Devices (PMD) Act
  - Mapping QMS to EU IVDR Requirements: 3 Key Takeaways to Effectively Strategize QMS Implementation
  - The Evolution of the Accreditation Scheme for Conformity Assessment (ASCA) for Medical Device Premarket Approval
  - MDR Update: Draft Corrigenda Published Outlining Positive Impact to Class I Manufacturers and Up-Classification Rules
  - Key Requirements of Post-Market Surveillance under IVDR
  - IVDR Technical Documentation: 5 Critical Parameters of Change You Must Understand
  - MDCG ISSUES Guidance on Summary of Safety and Clinical Performance under the Medical Device Regulation (MDR)
  - Chinese State Drug Administration Releases ‘Notice on the Implementation of Electronic Declaration of Medical Device Registration’
  - EU IVDR: Understanding the New QMS Requirements
  - FDA CDRH: New Organizational Structure Effective May 1, 2019
  - Draft Corrigenda for EU MDR and IVDR Released
  - EMA Issues Q&A Regarding Impact of MDR, Article 117
  - EU Issues Q&A Document to Provide Further Analysis of Potential No-Deal Brexit
  - UK MHRA Releases Contingency Legislation Covering Regulation of Medical Devices in Brexit ‘No Deal’ Scenario
  - EU Commission Updates Website to Provide Additional MDR and IVDR Planning Resources
  - Renewal Timelines Quickly Approaching for Medical Device Directive (MDD:M5) CE Mark Certificates
  - FDA Shifts 510(K) Paradigm, Announces Transformative Steps to Modernize 510(k) Program
  - NAMSA® Launches Chinese Website to Provide Medical Device Development Resource to APAC Sponsors
  - NAMSA® Launches Market Intelligence Report on Global Medical Device Clinical Outsourcing Trends
  - EU Commission & MDCG Release New MDR & IVDR Guidance Documents
  - FDA CDRH Reorganization: Faster Reviews for Medical Device Manufacturers?
  - Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard
  - FDA Announces FY19 User Fees
  - EU Commission Issues Supplementary Guidance Information for CE Marks Under MDR & IVDR
  - NAMSA® Launches "Uniquely IVD" Development Services to Expedite in vitro Diagnostic Technology Commercialization Efforts for Global Manufacturers
  - Mid-Year FDA Regulation & Guidance Review
  - FDA Issues New Draft Guidance Document for Pre-Submissions
  - EU MDR and IVDR Compliance Planning Resources
  - NAMSA Recognized as Leading Medical Device CRO for Second Consecutive Year by Life Science Leader
  - CE Marking of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR
  - Japan’s PMDA to Raise Medical Device and IVD Registration User Fees Beginning April 2018
  - NAMSA Introduces French Website to Provide Resource for Accelerated Medical Device Development in Europe
  - CFDA Releases Technical Guidelines for the Acceptance of Overseas Clinical Trial Data of Medical Devices
  - EU Commission Issues “Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products”
  - Obtaining Actionable FDA Feedback: How to Develop Targeted Questions for Pre-Submission Meetings
  - ISO 13485:2016 - Effective Preparation and Implementation of Medical Device Quality Management Systems
  - CFDA Releases “Amendments to the Regulations on the Supervision and Administration of Medical Devices” Exposure Draft
  - Japan’s “Ninsho Kijun” Regulatory Approval Pathway
  - Brexit and the Impact on UK Medical Device Operations
  - The Importance of Human Factors & Usability Engineering in Medical Devices
  - UK MHRA Publishes Guide to the New EU Medical Device and IVD Regulations
  - New Medical Device Classification Catalog Issued by the CFDA
  - The Value of Randomized Pilot Studies in Demonstrating Patient Safety and Efficacy
  - Japan’s PMDA Consultation Offering: A Beneficial Resource for Streamlined Device Approval
  - EU MDR Poses Significant Changes for Importers and Distributors
  - NAMSA Launches Japanese Website to Support Increased Demand for Medical Device Development Services
  - Focus on Japan Series: Part IV - Streamlining the Quality Management System Approval Process
  - China Releases Regulations for the Supervision and Administration of Medical Devices (No. 680)
  - Risk: An Emerging Driver for New Regulatory Requirements
  - Focus on Japan Series: Part III - Registering Facilities under Foreign Manufacturer Accreditation (FMA)
  - CFDA Announces “Administrative Measures on Communication with Applicants for the Technical Evaluation of Medical Device (Trial)"
  - MDR Transition Timelines for Legacy Medical Devices - Not without Risks and Undue Burden
  - Good News for Industry? How the Proposed FDA Class II Device Exemptions Will Impact Medical Device Manufacturers
  - EU Parliament Votes to Institute the New IVDR and MDR Regulations; Transition Period Expected to Begin on June 1, 2017
  - Why Regional Reimbursement Strategies Could Be Right For Medtech
  - France Imposes New Registration Requirement for Implantable and Class III Medical Device Manufacturers
  - Focus on Japan Series: Part II - Understanding the Designated Marketing Authorization (D-MAH) Status for Foreign Device Manufacturers
  - Planning for Success: UDI Requirements Under the EU MDD/MDR
  - Ensuring the Confidentiality of Chinese Medical Device Manufacturers
  - 2017 Medical Device Outlook: Five Potential Impacts to Global Device Organizations
  - Focus on Japan Series: Part I - Important Factors for Medical Device Development in Japan
  - Important Considerations for Labelling of Medical Devices Under the New EU MDR
  - Guidelines for Medical Device Development in Japan
  - Clinical Trials for Innovative Devices: Concurrent Review by FDA/CMS Leads to Time and Cost Efficiencies
  - CFDA Issues Announcement on Medical Device Priority Approval Procedures
  - CFDA Provisions for Medical Device Adverse Event Monitoring and Re-evaluation
  - The Three Pathways to Medical Device Registration in Japan
  - ISO 13485:2016 and Risk Management
  - Do I Need to Submit a New 510(k)?
  - CFDA Oversea GMP Inspections
  - FDA Warning Letters for Non-US Manufacturers
  - FDA Factors to Consider Regarding Benefit - Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions
  - MEDDEV 2.7.1 Revision 4 – Stricter Requirements for Clinical Evaluation Reports
  - Update on FDA’s Clinical Trials Program for Medical Devices
  - New Marketing Application Procedure for Combination Products in Japan
  - CFDA Releases Notice Regarding GSP Compliance for Medical Device Manufacturers
  - The New European MDR – Harmonization Effort with International Regulatory Requirements for Medical Devices
  - FDA Finalizes Biocompatibility Guidance for Medical Devices
  - Definition of “Regenerative Medical Products” in Japanese Law Has Been Revised
  - FDA Issues ‘Leap-Frog’ Guidance for 3D-Printed Medical Devices
  - CFDA is Collecting Comments on Clinical Exemption Catalogue
  - Human Factors / Usability Engineering in Product Design and Development
  - The Strategy of SAKIGAKE and How It Applies to Medical Devices
  - New Pre-Market Scrutiny Process for High-Risk Products in Europe
  - Industry Survey: FDA's Focus on Early Feasibility Studies
  - Unannounced Notified Body Audit
  - FDA Clarifies Policy for Color Additives in Medical Devices
  - Regenerative Medicine-Related Organizations and Activities in Japan
  - CFDA and NHFPC Jointly Issue Decree No. 25 The Good Clinical Practice for Medical Devices
  - PMDA Submission Strategy and CRO Limitations, Part 2
  - CFDA Authenticity Verification of Clinical Trial Data for Medical Device Kick Off
  - ISO 13485:2016 - Medical devices – Quality management systems – Requirements for regulatory purposes
  - The Importance of Applying Human Factors and Usability Engineering to Medical Devices
  - Steady Growth for China's Medical Device Fast Track Process
  - PMDA Submission Strategy and CRO Limitations, Part 1
  - Upcoming UDI Requirements and 2016 Compliance Dates for Labelers of Class II Medical Devices
  - China Acceptance of Foreign Biocompatibility Reports
  - Medical Device Development: Post-Market
  - Medical Device Development: Market Approval
  - Medical Device Development: Clinical Studies, Part 2
  - NAMSA White Paper: Risk-Based Monitoring: Considerations for Clinical Implementation
  - Medical Device Development: Clinical Studies, Part 1
  - Medical Device Development: Design Validation and Preclinical, Part 2
  - Medical Device Development: Design Validation and Preclinical, Part 1
  - NAMSA and Fortuna Clinical Form Strategic Relationship
  - Medical Device Development: Concept and Feasibility, Part 2
  - Medical Device Development: Concept and Feasibility, Part 1
  - Infographic: Common Mistakes in the Medical Device Development Continuum
  - NAMSA White Paper: Joining Preclinical and Clinical Development: A Practical Approach to Reducing Medical Device Timelines
  - Impacts and Obstacles of Innovation in Medical Devices
  - FDA Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Outside the US
  - Emerging and Re-Emerging Markets : How to Navigate Innovation Through Global Regulatory Approvals
  - Additional Information You Should Know Before Performing a Clinical Study
  - Examining the Progress of the Ongoing Revision of the Medical Device Directive
  - Moving From In Vitro to In Vivo: What Happens Next?
  - Differences and Similarities in Investigator Selection Between the US and EU
  - Things to Consider When Selecting a Clinical Investigator
  - De Novo Classification Process
  - FDA Guidance on Exemptions for Custom Devices
  - Selecting a CRO for Clinical Research
  - Selecting an Optimal Study Site in the EU
  - Updated German Legislation for Medical Devices
  - New Developments in FDA Biocompatibility Requirements for Personal Lubricants
  - China Regulation Updates
  - Conducting a Clinical Study in the US
  - New FDA Regulations on Laboratory-Developed Tests
  - Responsibilities of an Authorized Representative and US Agent
  - Updating a Clinical Evaluation Report (CER)
  - Bringing a Novel Medical Device or IVD to Market
  - The Need for an Agent for Clinical Trials in the US
  - EU Borderline Classification Manual Update
  - The Need for an Authorized Representative for Clinical Trials in the EU
  - Revised Code of Conduct for Notified Bodies
  - Update on the New EU IVD and Medical Device Regulations
  - Informed Consent - Time for Change
  - Insights for Clinical Management
  - Engaging the Best Notified Body to Certify Your Device in the EU
  - Meet with NAMSA on the Road
  - The FDA Acceptance Review and Refuse To Accept Processes for PMAs and 510(k)s
  - Unique Device Identifier Required for Class III Medical Devices
  - NAMSA Speakers Around the Globe
  - Optimizing Your Journey on the IDE Approval Pathway: The FDA Pre-Submission Program
  - CFDA Regulation Creates Changes in Chinese Regulatory Landscape
  - New FDA Guidance Regarding CLIA Categorization Process for IVDs
  - Final Pre-Submission Guidance Issued by FDA
  - Chinese Medical Device Market Continues to Grow
  - FDA Gives New IVD Guidance
  - NAMSA China Expands Expertise and Services
  - New Acceptance Review Processes for 510(k)s and PMAs
  - Remote Training Seminars Now Offered By NAMSA
European Market
- European Commission Mandate for EU Parliament Negotiations on MDR delay: Clarification regarding Article 120(3)
- EU Response to COVID-19 Pandemic: Proposal to Delay Date of MDR Application to May 2021 for Certain Provisions
- Mapping QMS to EU IVDR Requirements: 3 Key Takeaways to Effectively Strategize QMS Implementation
- MDR Update: Draft Corrigenda Published Outlining Positive Impact to Class I Manufacturers and Up-Classification Rules
- Key Requirements of Post-Market Surveillance under IVDR
- IVDR Technical Documentation: 5 Critical Parameters of Change You Must Understand
- NAMSA Expands European Medical Device Testing Solutions with DAkkS DIN ISO/IEC 17025:2018 Accreditation in Germany
- MDCG ISSUES Guidance on Summary of Safety and Clinical Performance under the Medical Device Regulation (MDR)
- Draft Corrigenda for EU MDR and IVDR Released
- EMA Issues Q&A Regarding Impact of MDR, Article 117
- EU Issues Q&A Document to Provide Further Analysis of Potential No-Deal Brexit
- UK MHRA Releases Contingency Legislation Covering Regulation of Medical Devices in Brexit ‘No Deal’ Scenario
- EU Commission Updates Website to Provide Additional MDR and IVDR Planning Resources
- Renewal Timelines Quickly Approaching for Medical Device Directive (MDD:M5) CE Mark Certificates
- EU Commission & MDCG Release New MDR & IVDR Guidance Documents
- Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard
- EU Commission Issues Supplementary Guidance Information for CE Marks Under MDR & IVDR
- EU MDR and IVDR Compliance Planning Resources
- CE Marking of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR
- NAMSA Introduces French Website to Provide Resource for Accelerated Medical Device Development in Europe
- EU Commission Issues “Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products”
- NAMSA Expands Medical Device Testing Services in Germany to Increase Access to Accelerated Product Development
- NAMSA Launches German Website to Support Europe’s Largest Medical Device Marketplace
- Brexit and the Impact on UK Medical Device Operations
- The Importance of Human Factors & Usability Engineering in Medical Devices
- UK MHRA Publishes Guide to the New EU Medical Device and IVD Regulations
- EU MDR Poses Significant Changes for Importers and Distributors
- Risk: An Emerging Driver for New Regulatory Requirements
- MDR Transition Timelines for Legacy Medical Devices - Not without Risks and Undue Burden
- EU Parliament Votes to Institute the New IVDR and MDR Regulations; Transition Period Expected to Begin on June 1, 2017
- France Imposes New Registration Requirement for Implantable and Class III Medical Device Manufacturers
- Planning for Success: UDI Requirements Under the EU MDD/MDR
- 2017 Medical Device Outlook: Five Potential Impacts to Global Device Organizations
- Important Considerations for Labelling of Medical Devices Under the New EU MDR
- ISO 13485:2016 and Risk Management
- FDA Warning Letters for Non-US Manufacturers
- MEDDEV 2.7.1 Revision 4 – Stricter Requirements for Clinical Evaluation Reports
- The New European MDR – Harmonization Effort with International Regulatory Requirements for Medical Devices
- Human Factors / Usability Engineering in Product Design and Development
- New Pre-Market Scrutiny Process for High-Risk Products in Europe
- Unannounced Notified Body Audit
- Medical Device Clinical Trials: SAE reporting requirements in Germany and Austria
- Obstacles in European Clinical Trials
- Differences and Similarities in Investigator Selection Between the US and EU
- Selecting a CRO for Clinical Research
- Selecting an Optimal Study Site in the EU
- Updated German Legislation for Medical Devices
- Responsibilities of an Authorized Representative and US Agent
- The Need for an Agent for Clinical Trials in the US
- EU Borderline Classification Manual Update
- The Need for an Authorized Representative for Clinical Trials in the EU
- Revised Code of Conduct for Notified Bodies
- Update on the New EU IVD and Medical Device Regulations
- Engaging the Best Notified Body to Certify Your Device in the EU
- CFDA Regulation Creates Changes in Chinese Regulatory Landscape
- Chinese Medical Device Market Continues to Grow
- The 2014 BPMDS Kicks Off In Germany
- Emerging Markets Theater - Life Science Alley Conference
- New EU Medical Device Legislation Proposal
- Developing a European First-In-Human (FIH) Study
FDA
- FDA Releases Final Guidance on Bone Anchor Premarket Notification (510(k)) Submissions
- U.S. FDA Announces eSTAR Pilot Program to Streamline 510(k) Submission Process
- The Evolution of the Accreditation Scheme for Conformity Assessment (ASCA) for Medical Device Premarket Approval
- FDA CDRH: New Organizational Structure Effective May 1, 2019
- FDA Shifts 510(K) Paradigm, Announces Transformative Steps to Modernize 510(k) Program
- FDA CDRH Reorganization: Faster Reviews for Medical Device Manufacturers?
- FDA Announces FY19 User Fees
- Mid-Year FDA Regulation & Guidance Review
- FDA Issues New Draft Guidance Document for Pre-Submissions
- Obtaining Actionable FDA Feedback: How to Develop Targeted Questions for Pre-Submission Meetings
- ISO 13485:2016 - Effective Preparation and Implementation of Medical Device Quality Management Systems
- White Paper: Utilizing Biological Risk Assessments and Chemical Characterization to Reduce Medical Device Development Timelines
- The Value of Randomized Pilot Studies in Demonstrating Patient Safety and Efficacy
- Good News for Industry? How the Proposed FDA Class II Device Exemptions Will Impact Medical Device Manufacturers
- Why Regional Reimbursement Strategies Could Be Right For Medtech
- France Imposes New Registration Requirement for Implantable and Class III Medical Device Manufacturers
- Planning for Success: UDI Requirements Under the EU MDD/MDR
- 2017 Medical Device Outlook: Five Potential Impacts to Global Device Organizations
- Clinical Trials for Innovative Devices: Concurrent Review by FDA/CMS Leads to Time and Cost Efficiencies
- Do I Need to Submit a New 510(k)?
- FDA Factors to Consider Regarding Benefit - Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions
- Update on FDA’s Clinical Trials Program for Medical Devices
- FDA Finalizes Biocompatibility Guidance for Medical Devices
- FDA Issues ‘Leap-Frog’ Guidance for 3D-Printed Medical Devices
- Industry Survey: FDA's Focus on Early Feasibility Studies
- FDA Clarifies Policy for Color Additives in Medical Devices
- The Importance of Applying Human Factors and Usability Engineering to Medical Devices
- Upcoming UDI Requirements and 2016 Compliance Dates for Labelers of Class II Medical Devices
- Medical Device Development: Post-Market
- Medical Device Development: Market Approval
- Traceability in Device Design, Development, and Distribution
- NAMSA White Paper: FDA Pre-Submission or Q-Sub Program
- NAMSA White Paper: Human Factors Studies in Medical Device Reprocessing
- NAMSA White Paper: Risk-Based Monitoring: A Cognizant Approach
- Infographic: Common Mistakes in the Medical Device Development Continuum
- Recommendations for Designing Studies for the Validation of Reprocessing Instructions
- FDA Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Outside the US
- Don Palme at MD&M Minneapolis
- Moving From In Vitro to In Vivo: What Happens Next?
- Differences and Similarities in Investigator Selection Between the US and EU
- Package Validation
- De Novo Classification Process
- FDA Guidance on Exemptions for Custom Devices
- Medibio Has Appointed NAMSA to Assist with Trial Design and Regulatory Discussion with the US FDA
- The Basics of Bone Implantation, Part 1: Why Bone Implantation?
- New Developments in FDA Biocompatibility Requirements for Personal Lubricants
- New FDA Regulations on Laboratory-Developed Tests
- The Need for an Agent for Clinical Trials in the US
- Informed Consent - Time for Change
- FDA Guidelines for Social Media Posts with Character Limitations
- The FDA Acceptance Review and Refuse To Accept Processes for PMAs and 510(k)s
- Independent Assessment of FDA Device Review Program Results in 11 Recommendations
- Unique Device Identifier Required for Class III Medical Devices
- Optimizing Your Journey on the IDE Approval Pathway: The FDA Pre-Submission Program
- Reusable Medical Device
- Final Pre-Submission Guidance Issued by FDA
- FDA to Propose Guidelines For Interoperable Medical Devices
- FDA Gives New IVD Guidance
- New Acceptance Review Processes for 510(k)s and PMAs
- FDA Regulation of Mobile Medical Applications
Industry Reposts
- MEDDEV 2.7.1 Revision 4 – Stricter Requirements for Clinical Evaluation Reports
- Is 2016 The Year That CMS Starts Fining Sunshine Act Violators?
- Infographic: Common Mistakes in the Medical Device Development Continuum
- Updated German Legislation for Medical Devices
- FDA Guidelines for Social Media Posts with Character Limitations
- Independent Assessment of FDA Device Review Program Results in 11 Recommendations
- New FDA Guidance Regarding CLIA Categorization Process for IVDs
- Final Pre-Submission Guidance Issued by FDA
- FDA to Propose Guidelines For Interoperable Medical Devices
IVD
- Diagnostic Developers Look to EUA Submission to Combat Novel Coronavirus (COVID-19)
- Mapping QMS to EU IVDR Requirements: 3 Key Takeaways to Effectively Strategize QMS Implementation
- EU IVDR: Understanding the New QMS Requirements
Microbiology
- NAMSA Launches Online Biocompatibility Strategy Application to Streamline Development Efforts for Global Medical Device Manufacturers
- White Paper: Utilizing Biological Risk Assessments and Chemical Characterization to Reduce Medical Device Development Timelines
- NAMSA Announces New Online Test Selection Tool to Support Global Medical Device Manufacturers
- Infographic: Common Mistakes in the Medical Device Development Continuum
- Recommendations for Designing Studies for the Validation of Reprocessing Instructions
- Introducing NAMSA Connect
- Reusable Medical Device
- NAMSA Irvine Facility Expands
MRO
- NAMSA® Launches Chinese Website to Provide Medical Device Development Resource to APAC Sponsors
- NAMSA® Launches Market Intelligence Report on Global Medical Device Clinical Outsourcing Trends
- NAMSA Launches Online Biocompatibility Strategy Application to Streamline Development Efforts for Global Medical Device Manufacturers
- NAMSA® Launches "Uniquely IVD" Development Services to Expedite in vitro Diagnostic Technology Commercialization Efforts for Global Manufacturers
- NAMSA Recognized as Leading Medical Device CRO for Second Consecutive Year by Life Science Leader
- The Value of Randomized Pilot Studies in Demonstrating Patient Safety and Efficacy
- NAMSA Expands Service Offering Expertise Into South America
- NAMSA and Fortuna Clinical Form Strategic Relationship
- Medical Device Development: Concept and Feasibility, Part 2
- Medical Device Development: Concept and Feasibility, Part 1
- Infographic: Common Mistakes in the Medical Device Development Continuum
- NAMSA White Paper: Joining Preclinical and Clinical Development: A Practical Approach to Reducing Medical Device Timelines
- NAMSA White Paper: MedTech Outsourcing: Is the Past Any Indication of the Future?
- China Regulation Updates
- Informed Consent - Time for Change
- Engaging the Best Notified Body to Certify Your Device in the EU
- NAMSA Receives AAALAC Accreditation for Preclinical Facility in Minnesota
- The FDA Acceptance Review and Refuse To Accept Processes for PMAs and 510(k)s
- Independent Assessment of FDA Device Review Program Results in 11 Recommendations
- Introducing NAMSA Connect
- NAMSA’s Cell Culture Capabilities
- Unique Device Identifier Required for Class III Medical Devices
- NAMSA's Anatomic Program
- Reusable Medical Device
- NAMSA China Expands Expertise and Services
- NAMSA Irvine Facility Expands
News
- NAMSA® Launches Chinese Website to Provide Medical Device Development Resource to APAC Sponsors
- NAMSA® Launches Market Intelligence Report on Global Medical Device Clinical Outsourcing Trends
- NAMSA Launches Online Biocompatibility Strategy Application to Streamline Development Efforts for Global Medical Device Manufacturers
- NAMSA® Launches "Uniquely IVD" Development Services to Expedite in vitro Diagnostic Technology Commercialization Efforts for Global Manufacturers
- NAMSA Recognized as Leading Medical Device CRO for Second Consecutive Year by Life Science Leader
- NAMSA Expands Service Network Expertise into Costa Rica
- NAMSA Expands Service Network Expertise into Brazil and Mexico
- NAMSA Announces Divestiture of its Sterility Assurance Products Division
- NAMSA Expands Service Offering Expertise Into South America
- NAMSA and Fortuna Clinical Form Strategic Relationship
- Announcing Construction of New Preclinical Laboratory for Medical Device Research in Shanghai, China
- Medibio Has Appointed NAMSA to Assist with Trial Design and Regulatory Discussion with the US FDA
- NAMSA Symposium Coming to China
- NAMSA Receives AAALAC Accreditation for Preclinical Facility in Minnesota
- Introducing NAMSA Connect
- Agenda Announced for Germany Symposium
- NAMSA Announces 2014 Remote Training Series Calendar
- The 2014 BPMDS Kicks Off In Germany
- NAMSA Acquires Medvance LTD., Expanding European Presence and Clinical and Consulting Services
- NAMSA Adds BMP-2 Assay to a Comprehensive Breadth of Solutions for DBM Testing
- NAMSA China Expands Expertise and Services
- Emerging Markets Theater - Life Science Alley Conference
- NAMSA Partners with Medipert
- NAMSA Irvine Facility Expands
- Remote Training Seminars Now Offered By NAMSA
- NAMSA to Sponsor and Speak at Biocompatibility and Performance of Medical Device Symposium in Minneapolis
- NAMSA Sponsoring Conference on Best Practices for Biocompatibility and Performance for Medical Devices
- NAMSA Expands State-Of-The-Art Laboratory in Lyon, France
- NAMSA Acquires The Integra Group, Expanding Imaging and Clinical Services
- NAMSA Rebrands Business Unit in France
- NAMSA Expands ICP Offering
- NAMSA Opens Frankfurt Office to Provide Clinical Trial and Regulatory Support
- NAMSA Renames Acquisition
- NAMSA to Expand Laboratory Facilities
- NAMSA Continues to Expand Materials Testing Capabilities
- 2012 Fee Schedule Update
- Press Release
  - NAMSA Expands European Medical Device Testing Solutions with DAkkS DIN ISO/IEC 17025:2018 Accreditation in Germany
  - NAMSA Recognized as Leading Medical Device CRO for Third Consecutive Year by Life Science Leader
  - NAMSA Announces Acquisition of Reimbursement Strategies, LLC, Expands Medical Device Development Portfolio
  - NAMSA® Launches Chinese Website to Provide Medical Device Development Resource to APAC Sponsors
  - NAMSA® Launches Market Intelligence Report on Global Medical Device Clinical Outsourcing Trends
  - NAMSA Launches Online Biocompatibility Strategy Application to Streamline Development Efforts for Global Medical Device Manufacturers
  - NAMSA® Launches "Uniquely IVD" Development Services to Expedite in vitro Diagnostic Technology Commercialization Efforts for Global Manufacturers
  - NAMSA Recognized as Leading Medical Device CRO for Second Consecutive Year by Life Science Leader
  - NAMSA Introduces French Website to Provide Resource for Accelerated Medical Device Development in Europe
  - NAMSA Expands Medical Device Testing Services in Germany to Increase Access to Accelerated Product Development
  - NAMSA Launches German Website to Support Europe’s Largest Medical Device Marketplace
  - NAMSA Announces New Online Test Selection Tool to Support Global Medical Device Manufacturers
  - NAMSA Launches Japanese Website to Support Increased Demand for Medical Device Development Services
  - NAMSA Celebrates 50 Years of Scientific Innovation in the Medtech Industry
  - NAMSA Recognized as a Premier International CRO by Life Science Leader
  - NAMSA and NAGLREITER Partner to Provide Innovative Development Solution to Global Medical Device Manufacturers
  - NAMSA Broadens Global Reach of Medical Device Development Summits to Increase Access to Industry Experts
  - NAMSA Expands Medical Device Clinical and Consulting Services Presence in Minneapolis to Accommodate Growth
  - NAMSA Expands Service Offering in China with Opening of Shanghai Laboratory
  - NAMSA Expands Service Network Expertise into Costa Rica
  - NAMSA Expands Service Network Expertise into Brazil and Mexico
  - NAMSA Announces Divestiture of its Sterility Assurance Products Division
  - NAMSA Expands Service Offering Expertise Into South America
  - NAMSA and Fortuna Clinical Form Strategic Relationship
  - Announcing Construction of New Preclinical Laboratory for Medical Device Research in Shanghai, China
  - NAMSA Acquires Medvance LTD., Expanding European Presence and Clinical and Consulting Services
  - NAMSA Acquires The Integra Group, Expanding Imaging and Clinical Services
Packaging & Stability
- Ready for DuPont’s Transition Tyvek®? NAMSA Can Help!!
- Medical Device Development: Design Validation and Preclinical, Part 2
- Medical Device Development: Design Validation and Preclinical, Part 1
- Infographic: Common Mistakes in the Medical Device Development Continuum
- Recommendations for Designing Studies for the Validation of Reprocessing Instructions
- Package Validation
- NAMSA Shelf Life Validation
Preclinical
- China Acceptance of Foreign Biocompatibility Reports
- NAMSA Expands Service Offering Expertise Into South America
- Traceability in Device Design, Development, and Distribution
- Medical Device Development: Design Validation and Preclinical, Part 2
- Medical Device Development: Design Validation and Preclinical, Part 1
- NAMSA and Fortuna Clinical Form Strategic Relationship
- Infographic: Common Mistakes in the Medical Device Development Continuum
- NAMSA White Paper: Joining Preclinical and Clinical Development: A Practical Approach to Reducing Medical Device Timelines
- Announcing Construction of New Preclinical Laboratory for Medical Device Research in Shanghai, China
- Evaluation of Tissue Regeneration as Support in Translative Research
- Advances in Medical Device Materials. Part 2: Synthetic Collagen Fibers & Trimethylene Carbonate/Lactide/Glycolide Polymers
- Advances in Medical Device Materials. Part 1: Polycarbonate Resins
- The Basics of Bone Implantation, Part 3: Evaluation of a Bone Implantation Study
- UPLC/MS
- Don Palme at MD&M Minneapolis
- Moving From In Vitro to In Vivo: What Happens Next?
- The Basics of Bone Implantation, Part 2: Designing an Effective Bone Implantation Study
- The Basics of Bone Implantation, Part 1: Why Bone Implantation?
- New Developments in FDA Biocompatibility Requirements for Personal Lubricants
- New FDA Regulations on Laboratory-Developed Tests
- A Recent Human Anatomic Study Conducted with NAMSA
- Insights for Clinical Management
- NAMSA Receives AAALAC Accreditation for Preclinical Facility in Minnesota
- Introducing NAMSA Connect
- NAMSA’s Cell Culture Capabilities
Toxicology
- NAMSA Launches Online Biocompatibility Strategy Application to Streamline Development Efforts for Global Medical Device Manufacturers
- NAMSA Announces New Online Test Selection Tool to Support Global Medical Device Manufacturers
- Medical Device Development: Design Validation and Preclinical, Part 2
- Medical Device Development: Design Validation and Preclinical, Part 1
- Infographic: Common Mistakes in the Medical Device Development Continuum
- Evaluation of Tissue Regeneration as Support in Translative Research
- The Basics of Bone Implantation, Part 3: Evaluation of a Bone Implantation Study
- Don Palme at MD&M Minneapolis
- Moving From In Vitro to In Vivo: What Happens Next?
- The Basics of Bone Implantation, Part 2: Designing an Effective Bone Implantation Study
- The Basics of Bone Implantation, Part 1: Why Bone Implantation?
- New Developments in FDA Biocompatibility Requirements for Personal Lubricants
- Insights for Clinical Management
- Introducing NAMSA Connect
- NAMSA Speakers Around the Globe
- NAMSA's Anatomic Program
- Continuous Preclinical Monitoring in Medical Device Studies
- USP Class Testing
- Chinese Medical Device Market Continues to Grow
- The 2014 BPMDS Kicks Off In Germany
- NAMSA Adds BMP-2 Assay to a Comprehensive Breadth of Solutions for DBM Testing

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