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 …
Recent Articles
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 …
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 …
Social Media
Friday, August 17th, 2018 at 10:18am
Join NAMSA October 1 - 4 in Boston, MA for our highly sought-out Biological Safety Training! Early bird registration ends August 20. https://t.co/IzzqvZylLz #MRO #CRO #medtech #medicaldevice #biological safety https://t.co/QSGxOSSePs
Join NAMSA October 1 - 4 in Boston, MA for our highly sought-out Biological Safety Training! Early bird registration ends August 20. https://t.co/IzzqvZylLz #MRO #CRO #medtech #medicaldevice #biological safety https://t.co/QSGxOSSePs
Friday, August 17th, 2018 at 6:04am
NAMSA invites you to read our Emerging Medical Device Markets in Latin America white paper which provides critical insights into existing opportunities and risks for consideration for device manufacturers when navigating Latin America. https://t.co/DF0PL4m3K4 #medtech #LATAM https://t.co/OEkJa3oCZg
NAMSA invites you to read our Emerging Medical Device Markets in Latin America white paper which provides critical insights into existing opportunities and risks for consideration for device manufacturers when navigating Latin America. https://t.co/DF0PL4m3K4 #medtech #LATAM https://t.co/OEkJa3oCZg
Thursday, August 16th, 2018 at 8:05am
To help #EU device manufacturers navigate the EN ISO 14971 Medical Device Risk Management Standard, NAMSA’s latest blog provides information on the most significant changes and suggested processes on how to appropriately address risk.
https://t.co/UzayGe6CzU #CRO #ISO #medtech https://t.co/5jt9xMvZQ8
To help #EU device manufacturers navigate the EN ISO 14971 Medical Device Risk Management Standard, NAMSA’s latest blog provides information on the most significant changes and suggested processes on how to appropriately address risk.
https://t.co/UzayGe6CzU #CRO #ISO #medtech https://t.co/5jt9xMvZQ8
Thursday, August 16th, 2018 at 6:02am
NAMSA's Training Series are interactive events intended to promote engagement between attendees and industry thought leaders. Shared are best practices, proven strategies and resources critical to efficient product development. Learn more: https://t.co/zIwJAYN1fZ #medtech #CRO https://t.co/7ZwYcsoxEv
NAMSA's Training Series are interactive events intended to promote engagement between attendees and industry thought leaders. Shared are best practices, proven strategies and resources critical to efficient product development. Learn more: https://t.co/zIwJAYN1fZ #medtech #CRO https://t.co/7ZwYcsoxEv
Wednesday, August 15th, 2018 at 10:01am
Is your #CRO dedicated to helping you overcome hurdles and mitigate development risks? Learn how a NAMSA partnership consistently delivers clients expedited timelines and cost savings. https://t.co/ca1OB3KSPi #medtech #medicaldevice #MRO https://t.co/3yvCczx9YT
Is your #CRO dedicated to helping you overcome hurdles and mitigate development risks? Learn how a NAMSA partnership consistently delivers clients expedited timelines and cost savings. https://t.co/ca1OB3KSPi #medtech #medicaldevice #MRO https://t.co/3yvCczx9YT
Wednesday, August 15th, 2018 at 6:04am
Only a few seats left! 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/JJEGNXAaD4 #medtech #toxicology @PaceLabs https://t.co/7AkK5w1edW
Only a few seats left! 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/JJEGNXAaD4 #medtech #toxicology @PaceLabs https://t.co/7AkK5w1edW
Trending Articles
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 …
Responsibilities of an Authorized Representative and US Agent
Regulatory agencies in the EU and US set the requirements for representation and also define a number of responsibilities for organizations acting on behalf of another company. Levels of responsibility …
Brexit and the Impact on UK Medical Device Operations
On 23 June 2016, more than 30 million citizens in the United Kingdom (UK) voted in a referendum to determine whether the country should leave or remain part of the …