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
Monday, June 26th, 2017 at 10:31am
NAMSA to present FDA/CMS Parallel Review Process webinar with FDA's Ken Skodacek (Policy Analyst) on 7/18.
https://t.co/0TryGDXixK
NAMSA to present FDA/CMS Parallel Review Process webinar with FDA's Ken Skodacek (Policy Analyst) on 7/18.
https://t.co/0TryGDXixK
Thursday, June 22nd, 2017 at 10:35am
Register for our upcoming webinar on July 20: "Understanding Medical Device Regulatory Pathways in China and Japan" https://t.co/a65IwZtG2D https://t.co/3qFsUBZ4NE
Register for our upcoming webinar on July 20: "Understanding Medical Device Regulatory Pathways in China and Japan" https://t.co/a65IwZtG2D https://t.co/3qFsUBZ4NE
Wednesday, June 21st, 2017 at 1:22pm
Registration is now open for NAMSA's Biological Safety Training in Stuttgart, Germany (Oct. 9-12). https://t.co/2UWkIncimR #CRO #MRO https://t.co/ir9hsGKFsk
Registration is now open for NAMSA's Biological Safety Training in Stuttgart, Germany (Oct. 9-12). https://t.co/2UWkIncimR #CRO #MRO https://t.co/ir9hsGKFsk
Wednesday, June 21st, 2017 at 9:10am
Webinar: The Value of Preclinical Studies from Concept to Commercialization
7/13: https://t.co/CTLPSBFG6O
7/14: https://t.co/Fqb7kHjvwH https://t.co/k4WBfI7r12
Webinar: The Value of Preclinical Studies from Concept to Commercialization
7/13: https://t.co/CTLPSBFG6O
7/14: https://t.co/Fqb7kHjvwH https://t.co/k4WBfI7r12
Tuesday, June 20th, 2017 at 12:38pm
Registration now open for NAMSA's Biological Safety Training in Philadelphia (9/25-9/28)!
https://t.co/Au3Xx8BbqO https://t.co/2YWTTVipoa
Registration now open for NAMSA's Biological Safety Training in Philadelphia (9/25-9/28)!
https://t.co/Au3Xx8BbqO https://t.co/2YWTTVipoa
Monday, June 19th, 2017 at 9:13am
Join us @DeviceTalks on 6/27 (3-4 PM) to learn more about new developments in the world of reimbursement. https://t.co/wCIJJdNnu1 #CRO #MRO https://t.co/sYkevWev7d
Join us @DeviceTalks on 6/27 (3-4 PM) to learn more about new developments in the world of reimbursement. https://t.co/wCIJJdNnu1 #CRO #MRO https://t.co/sYkevWev7d
Trending Articles
A Recent Human Anatomic Study Conducted with NAMSA
One of our clients recently conducted a human anatomic study to evaluate the deployment of percutaneous aortic valves. The study utilized whole-body cadaveric specimens and a pressurized flow circuit to …
NAMSA’s Cell Culture Capabilities
NAMSA’s laboratory in Brooklyn Park, Minnesota recently made two major purchases in order to establish cell culture capabilities. These purchases include a CO2 incubator and cryostat. While most of the …