The first half of October experienced a (small) flurry of activity from key stakeholders implementing the European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). In …
Recent Articles
Effective Implementation of EN ISO 14971 Medical Device Risk Management Standard
Risk management is an important lifecycle product development requirement for all medical device organizations when developing, manufacturing, and commercially distributing medical products. To appropriately address issues of potential risk within …
EU Commission Issues Supplementary Guidance Information for CE Marks Under MDR & IVDR
Since the approval of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) by the EU Commission on 5 April 2017, the lack of substantive guidance …
EU MDR and IVDR Compliance Planning Resources
The European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), originally published on 05 May 2017 by the EU Parliament, set forth new and important requirements for medical …
CE Marking of Digital Health Technologies: Stricter Rules for Medical Device Software under the EU MDR
Introduction Increasingly, the world is engaged in conversations surrounding mobile and digital health applications. These types of platforms – broadly defined – encompass everything from pedometers, fitness apps, exercise diaries …
Social Media
Friday, December 7th, 2018 at 8:46am
Just Announced! #FDA opens comment period for medical device De Novo classification process requirements. Learn more: https://t.co/QKxDFEmR3w #denovo #PMA #CDRH #regulatory #medicaldevice #medtech https://t.co/5Ik9STIZYj
Just Announced! #FDA opens comment period for medical device De Novo classification process requirements. Learn more: https://t.co/QKxDFEmR3w #denovo #PMA #CDRH #regulatory #medicaldevice #medtech https://t.co/5Ik9STIZYj
Monday, December 3rd, 2018 at 6:01am
Listen to NAMSA’s latest recorded webinar to review major changes and testing strategies to efficaciously prepare for implementation (presented by biological safety expert, Don Pohl). Access here: https://t.co/6uzPk6BYBo #ISO #biologicalsafety https://t.co/GTgV5Po6mO
Listen to NAMSA’s latest recorded webinar to review major changes and testing strategies to efficaciously prepare for implementation (presented by biological safety expert, Don Pohl). Access here: https://t.co/6uzPk6BYBo #ISO #biologicalsafety https://t.co/GTgV5Po6mO
Friday, November 30th, 2018 at 6:02am
NAMSA Training Series offers industry-leading educational programs that provide expertise and insight into critical medical device topics (certifications available). Register today! https://t.co/vNBLPkitB3 #medtech #medicaldevice #biologicalsafety https://t.co/8EULMvAuhE
NAMSA Training Series offers industry-leading educational programs that provide expertise and insight into critical medical device topics (certifications available). Register today! https://t.co/vNBLPkitB3 #medtech #medicaldevice #biologicalsafety https://t.co/8EULMvAuhE
Thursday, November 29th, 2018 at 8:02am
Have you accessed NAMSA’s 2018 “Medical Device Landscape Report: Trends & Challenges in Clinical Research Outsourcing” yet? Download your copy today! https://t.co/hZtkkd6vC6 #clinical #medicaldevice #medtech #CRO https://t.co/aJAQOEkZqo
Have you accessed NAMSA’s 2018 “Medical Device Landscape Report: Trends & Challenges in Clinical Research Outsourcing” yet? Download your copy today! https://t.co/hZtkkd6vC6 #clinical #medicaldevice #medtech #CRO https://t.co/aJAQOEkZqo
Wednesday, November 28th, 2018 at 11:29am
On Nov. 26, the #FDA issued proposed changes to the agency’s 510(k) program, including updated criteria for U.S. manufacturers seeking approval via predicate devices. What do these changes mean for industry? Read more:
https://t.co/XfMnQijpOB https://t.co/tmhgdE02fW
On Nov. 26, the #FDA issued proposed changes to the agency’s 510(k) program, including updated criteria for U.S. manufacturers seeking approval via predicate devices. What do these changes mean for industry? Read more:
https://t.co/XfMnQijpOB https://t.co/tmhgdE02fW
Wednesday, November 21st, 2018 at 6:00am
NAMSA invites you to join us at the Q1 Productions 11th Annual IVD Regulatory Affairs Conference in Alexandria, VA on December 5-6. Learn more: https://t.co/Z3AbgLyHCS #IVD #IVDR #medtech https://t.co/A2FGszwtQh
NAMSA invites you to join us at the Q1 Productions 11th Annual IVD Regulatory Affairs Conference in Alexandria, VA on December 5-6. Learn more: https://t.co/Z3AbgLyHCS #IVD #IVDR #medtech https://t.co/A2FGszwtQh
Trending Articles
MEDDEV 2.7.1 Revision 4 – Stricter Requirements for Clinical Evaluation Reports
After some delays, Revision 4 of Clinical Evaluation MEDDEV guidance document 2.7.1 was released by the European Commission on July 1, 2016. Although the new revision is slightly larger in …
EU Commission Issues Supplementary Guidance Information for CE Marks Under MDR & IVDR
Since the approval of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) by the EU Commission on 5 April 2017, the lack of substantive guidance …
FDA Warning Letters for Non-US Manufacturers
The US Food and Drug Administration (FDA) has recently released information on 14 warning letters to non-US device manufactures. These letters were delivered from the Center for Devices and Radiological …