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
Wednesday, June 12th, 2019 at 7:20am
Press Release: NAMSA recognized as a leading medical device CRO for third consecutive year by Life Science Leader; honored as a top performer in the categories of Capabilities, Compatibility and Quality. Read more: https://t.co/P4sNqfzPix #MRO #CRO #medtech #medicaldevice https://t.co/7OeXxnV119
Press Release: NAMSA recognized as a leading medical device CRO for third consecutive year by Life Science Leader; honored as a top performer in the categories of Capabilities, Compatibility and Quality. Read more: https://t.co/P4sNqfzPix #MRO #CRO #medtech #medicaldevice https://t.co/7OeXxnV119
Tuesday, June 11th, 2019 at 8:47am
Full house today at our #Biocompatibility and #Microbiology Training Series in Austin, TX! Were you unable to attend? No worries! We offer our Training Series throughout the year at different global locations. Learn more: https://t.co/ijOW4lmKY6 #medtech #medicaldevice #CRO #MRO https://t.co/cASSaV7G0r
Full house today at our #Biocompatibility and #Microbiology Training Series in Austin, TX! Were you unable to attend? No worries! We offer our Training Series throughout the year at different global locations. Learn more: https://t.co/ijOW4lmKY6 #medtech #medicaldevice #CRO #MRO https://t.co/cASSaV7G0r
Monday, June 10th, 2019 at 10:17am
In November 2018, CMDE developed draft guidelines regarding clinical trials performed on IVD reagents. Access NAMSA’s latest white paper to learn about these guidelines and how #IVD manufacturers can prepare for compliance. https://t.co/nWdOLi3eG8 #China https://t.co/QZ5k5kkN22
In November 2018, CMDE developed draft guidelines regarding clinical trials performed on IVD reagents. Access NAMSA’s latest white paper to learn about these guidelines and how #IVD manufacturers can prepare for compliance. https://t.co/nWdOLi3eG8 #China https://t.co/QZ5k5kkN22
Friday, June 7th, 2019 at 5:06am
Join NAMSA at MedFIT on 25 – 26 June. Stop by Booth #C2 and visit with NAMSA’s #medicaldevice development experts. To learn more, or to set up a complimentary consultation, visit: https://t.co/lfvxeM0BMR #medtech #MRO #CRO https://t.co/zkTDaEb82l
Join NAMSA at MedFIT on 25 – 26 June. Stop by Booth #C2 and visit with NAMSA’s #medicaldevice development experts. To learn more, or to set up a complimentary consultation, visit: https://t.co/lfvxeM0BMR #medtech #MRO #CRO https://t.co/zkTDaEb82l
Thursday, June 6th, 2019 at 5:35am
NAMSA invites you to meet with us at the upcoming EU #MDR and #IVDR MedTech Summit in Brussels, Belgium. NAMSA’s Clinical Study Manager, Deborah Klestadt, will present a session on 18 June regarding post-market clinical follow up. https://t.co/DlVwFXjKkX #medtech #clinical https://t.co/4RrmaPINdY
NAMSA invites you to meet with us at the upcoming EU #MDR and #IVDR MedTech Summit in Brussels, Belgium. NAMSA’s Clinical Study Manager, Deborah Klestadt, will present a session on 18 June regarding post-market clinical follow up. https://t.co/DlVwFXjKkX #medtech #clinical https://t.co/4RrmaPINdY
Wednesday, June 5th, 2019 at 8:54am
NAMSA invites you to read our latest blog post, “Three Essentials for Smart IVD Clinical Trial Design.” https://t.co/eX68RzruZh #medtech #biotech #CRO #MRO #medicaldevice #IVD #clinical https://t.co/YE0Y7WXZkZ
NAMSA invites you to read our latest blog post, “Three Essentials for Smart IVD Clinical Trial Design.” https://t.co/eX68RzruZh #medtech #biotech #CRO #MRO #medicaldevice #IVD #clinical https://t.co/YE0Y7WXZkZ
Trending Articles
Advances in Medical Device Materials. Part 1: Polycarbonate Resins
Polycarbonate resins are being used to create promising and versatile new high-performance materials that can be tailored to meet multiple needs: Optical clarity and colorability Durability/impact resistance Ductility for rigorous …
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 …