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 …
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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 …
NAMSA Introduces French Website to Provide Resource for Accelerated Medical Device Development in Europe
28 FEBRUARY 2018 – LYON, FRANCE – (BUSINESS WIRE) – NAMSA, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory, clinical research and regulatory consulting …
EU Commission Issues “Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products”
On 10 January 2018, the EU Commission issued the document, “Notice to Stakeholders: Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products.” While this notice …
NAMSA Expands Medical Device Testing Services in Germany to Increase Access to Accelerated Product Development
The world’s only Medical Research Organization brings 50 years of testing leadership to Germany with new Analytical Services Laboratory. FRANKFURT, GERMANY – February 1, 2018 – NAMSA, the world’s only …
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Thursday, June 14th, 2018 at 9:30am
Limited Seating Event! Don’t miss the inaugural North American Biocompatibility Summit (NABS), an exclusive event that will provide industry insights and expertise on the #biocompatibility of medical devices. Register today: https://t.co/k2sjrzoHuE #medtech @PaceLabs https://t.co/dFwfz7jdpF
Limited Seating Event! Don’t miss the inaugural North American Biocompatibility Summit (NABS), an exclusive event that will provide industry insights and expertise on the #biocompatibility of medical devices. Register today: https://t.co/k2sjrzoHuE #medtech @PaceLabs https://t.co/dFwfz7jdpF
Thursday, June 14th, 2018 at 6:22am
Complimentary Webinar | July 26 | 10-11 AM ET U.S. | Join us for a discussion on new and modified methods for irradiation #sterilization, validation strategies for the design and manufacture of low/high bioburden devices, and more. https://t.co/aqXZ5aCesN #medtech #medicaldevice https://t.co/tTzVJJEFJL
Complimentary Webinar | July 26 | 10-11 AM ET U.S. | Join us for a discussion on new and modified methods for irradiation #sterilization, validation strategies for the design and manufacture of low/high bioburden devices, and more. https://t.co/aqXZ5aCesN #medtech #medicaldevice https://t.co/tTzVJJEFJL
Wednesday, June 13th, 2018 at 5:35am
Last chance! NAMSA’s global Biological Safety experts will present a training series on June 25-27 in Israel discussing best practices, proven strategies, and more. Make sure you’re set up for #medicaldevice development success! https://t.co/58eg5nUhGI #MRO #CRO #medtech https://t.co/xcY2Qqm9VR
Last chance! NAMSA’s global Biological Safety experts will present a training series on June 25-27 in Israel discussing best practices, proven strategies, and more. Make sure you’re set up for #medicaldevice development success! https://t.co/58eg5nUhGI #MRO #CRO #medtech https://t.co/xcY2Qqm9VR
Tuesday, June 12th, 2018 at 8:06am
NAMSA’s Contract Research Organization #CRO) services are designed around one goal: achieving client success. Our testing, clinical and consulting experts respond quickly to provide exceptional service. Learn more: https://t.co/yufvcjeAOz #medtech #medicaldevice #MRO https://t.co/PXaovU4kha
NAMSA’s Contract Research Organization #CRO) services are designed around one goal: achieving client success. Our testing, clinical and consulting experts respond quickly to provide exceptional service. Learn more: https://t.co/yufvcjeAOz #medtech #medicaldevice #MRO https://t.co/PXaovU4kha
Monday, June 11th, 2018 at 9:05am
NAMSA Blog Post: #FDA Issues Draft Guidance for Pre-Submissions; Some Feedback Timelines Reduced from 70 Days to 21. Learn more about how this could impact your regulatory business operations: https://t.co/dYBrWlrvjH #medtech #medicaldevice #MRO #CRO https://t.co/0B65T7pyLt
NAMSA Blog Post: #FDA Issues Draft Guidance for Pre-Submissions; Some Feedback Timelines Reduced from 70 Days to 21. Learn more about how this could impact your regulatory business operations: https://t.co/dYBrWlrvjH #medtech #medicaldevice #MRO #CRO https://t.co/0B65T7pyLt
Monday, June 11th, 2018 at 6:32am
Complimentary Webinar | July 12 | 10-11 AM ET U.S. | NAMSA invites you to our online event that will discuss #FDA chemical characterization requirements and how these may be utilized to cost-effectively assess patient impact and biological safety. https://t.co/YrxPoCM6vy #medtech https://t.co/UlMVu9pHP2
Complimentary Webinar | July 12 | 10-11 AM ET U.S. | NAMSA invites you to our online event that will discuss #FDA chemical characterization requirements and how these may be utilized to cost-effectively assess patient impact and biological safety. https://t.co/YrxPoCM6vy #medtech https://t.co/UlMVu9pHP2
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Responsibilities of an Authorized Representative and US Agent
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ISO 13485:2016 and Risk Management
The term “risk” is referenced over 15 times in the revised Quality Management Standard (QMS) ISO 13485:2016. This is considerably more as compared to the previous revision, where it is …
The New European MDR – Harmonization Effort with International Regulatory Requirements for Medical Devices
On May 25th, 2016, the European Commission released the long awaited draft for the proposed European Medical Device Regulation (MDR). Though not in its final implementation format, the consolidated text …