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
Thursday, October 18th, 2018 at 12:02pm
As #IVD markets and regulations change, it’s imperative to stay up-to-date on clinical trial components required to facilitate efficient, cost-effective market approvals. Join us for our upcoming webinar to learn more: https://t.co/lYHlTbJ5MK #CRO #MRO #medtech #EU #IVDR https://t.co/zGYdU8v9tw
As #IVD markets and regulations change, it’s imperative to stay up-to-date on clinical trial components required to facilitate efficient, cost-effective market approvals. Join us for our upcoming webinar to learn more: https://t.co/lYHlTbJ5MK #CRO #MRO #medtech #EU #IVDR https://t.co/zGYdU8v9tw
Wednesday, October 17th, 2018 at 2:34pm
The #EU Commission and #MDCG just released #MDR and #IVDR guidance documents, including templates for Field Safety Notices (FSN) under the existing EU Directives. Access our @NAMSA_MRO's #blog post to learn more: https://t.co/y6HoawOMVX #medicaldevice #medtech #MRO #CRO https://t.co/YHoYOiYIiG
The #EU Commission and #MDCG just released #MDR and #IVDR guidance documents, including templates for Field Safety Notices (FSN) under the existing EU Directives. Access our @NAMSA_MRO's #blog post to learn more: https://t.co/y6HoawOMVX #medicaldevice #medtech #MRO #CRO https://t.co/YHoYOiYIiG
Wednesday, October 10th, 2018 at 9:57am
@DeviceTalks? Stop by to learn how NAGLREITER and NAMSA are partnering to provide device manufacturers time and cost savings throughout the development continuum: Booth #615! https://t.co/LaAhzgs1qD https://t.co/rlh7GVHD0g
@DeviceTalks? Stop by to learn how NAGLREITER and NAMSA are partnering to provide device manufacturers time and cost savings throughout the development continuum: Booth #615! https://t.co/LaAhzgs1qD https://t.co/rlh7GVHD0g
Wednesday, October 10th, 2018 at 8:06am
Learn direct from the experts! Join NAMSA for the MD&M session: "Employing Evolutionary Design while Satisfying the Requirements for an FDA-Compliant Process,” on Oct. 31 from 8:30-10:00 AM CT. More info here: https://t.co/dlwKJwW1P7 #medtech #medicadevice #FDA https://t.co/N8fyk6hG6z
Learn direct from the experts! Join NAMSA for the MD&M session: "Employing Evolutionary Design while Satisfying the Requirements for an FDA-Compliant Process,” on Oct. 31 from 8:30-10:00 AM CT. More info here: https://t.co/dlwKJwW1P7 #medtech #medicadevice #FDA https://t.co/N8fyk6hG6z
Monday, October 8th, 2018 at 8:23am
Join NAMSA this week @DeviceTalks! Stop by Booth #615 to learn how our proven regulatory consulting and clinical research services provide clients time and cost efficiencies throughout the medical device development continuum. #CRO #MRO #medtech
https://t.co/rSpaHum9Vz https://t.co/pjWPXVF7zB
Join NAMSA this week @DeviceTalks! Stop by Booth #615 to learn how our proven regulatory consulting and clinical research services provide clients time and cost efficiencies throughout the medical device development continuum. #CRO #MRO #medtech
https://t.co/rSpaHum9Vz https://t.co/pjWPXVF7zB
Friday, October 5th, 2018 at 11:24am
NAMSA Training Series offers industry-leading educational programs that provide expertise and insight into critical medical device topics. Join us for our European biological safety programs - these sessions will sell out quickly – register today! https://t.co/cDeCiiHtd6 https://t.co/rsiN0iuHi8
NAMSA Training Series offers industry-leading educational programs that provide expertise and insight into critical medical device topics. Join us for our European biological safety programs - these sessions will sell out quickly – register today! https://t.co/cDeCiiHtd6 https://t.co/rsiN0iuHi8
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 …