The most recently revised “Medical Device Registration” and “in vitro diagnostic reagents Registration” (China Food and Drug Administration Order No. 4 an No. 5) came into effect October 1, 2014. To address …
Recent Articles
NAMSA Expands Service Offering Expertise Into South America
Northwood, OH – October 2015 – NAMSA, the world’s leading medical research organization is pleased to announce the addition of Blanchard & Associates as NAMSA’s local agent in South America. …
Traceability in Device Design, Development, and Distribution
The path through medical device design, testing, application, and maintenance needs to be traceable. Traceability analyses aid in understanding device design and whether requirements are being met. According to FDA, …
Medical Device Development: Design Validation and Preclinical, Part 2
Packaging and sterilization. Aside from the safety and efficacy of the device itself, the packaging and final processing must also be considered. The packaging material selection should be based on …
Medical Device Development: Design Validation and Preclinical, Part 1
The preclinical stage of device development is a vital one for medical device manufacturers. This is the stage in which the design of the product is set, including functionality and …
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
Introducing NAMSA Connect
Working with NAMSA just got a little easier. NAMSA Connect is a new secure online client portal and data access tool that provides 24/7 availability of test statuses, final reports, …
Infographic: Common Mistakes in the Medical Device Development Continuum
Getting a medical device to market is a long process made up of multiple stages. Each stage requires a number of elements that need to be considered before progress can …
Traceability in Device Design, Development, and Distribution
The path through medical device design, testing, application, and maintenance needs to be traceable. Traceability analyses aid in understanding device design and whether requirements are being met. According to FDA, …