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  • Asian Market
    • 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
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    • 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
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    • 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
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    • The 2014 BPMDS Kicks Off In Germany
    • NAMSA China Expands Expertise and Services
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    • NAMSA Launches Online Biocompatibility Strategy Application to Streamline Development Efforts for Global Medical Device Manufacturers
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    • MDR Update: Draft Corrigenda Published Outlining Positive Impact to Class I Manufacturers and Up-Classification Rules
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    • NAMSA® Launches Chinese Website to Provide Medical Device Development Resource to APAC Sponsors
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    • 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
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    • Infographic: Common Mistakes in the Medical Device Development Continuum
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    • 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
      • 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
    • 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
    • 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
    • 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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