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, April 18th, 2019 at 6:04am
NAMSA Training Series offers industry-leading educational programs that provide expertise and insight into critical #medicaldevice topics. Join us for our upcoming trainings (certifications available). Register today! https://t.co/aoNUUhWbCv #medtech #biologicalsafety #EU #MDR https://t.co/zdU6oSsGvl
NAMSA Training Series offers industry-leading educational programs that provide expertise and insight into critical #medicaldevice topics. Join us for our upcoming trainings (certifications available). Register today! https://t.co/aoNUUhWbCv #medtech #biologicalsafety #EU #MDR https://t.co/zdU6oSsGvl
Wednesday, April 17th, 2019 at 6:00am
NAMSA is partnering with MassMEDIC on April 30 for a special one-day event, “Biological Safety of Medical Devices: Updates and Challenges.” To learn more, or to register, visit: https://t.co/PFa3p3esvt Discount available for MassMEDIC members. #biologicalsafety #medtech #MDR https://t.co/20tALKqtvO
NAMSA is partnering with MassMEDIC on April 30 for a special one-day event, “Biological Safety of Medical Devices: Updates and Challenges.” To learn more, or to register, visit: https://t.co/PFa3p3esvt Discount available for MassMEDIC members. #biologicalsafety #medtech #MDR https://t.co/20tALKqtvO
Tuesday, April 16th, 2019 at 8:01am
How could your #medicaldevice organization further leverage OUS #clinical data to comply with the #FDA’s updated IDE and PMA submission regulations? Join NAMSA tomorrow (April 17) for our complimentary webinar. To register, visit: https://t.co/p0gWEQlKMG #medtech https://t.co/zKss8aOTB3
How could your #medicaldevice organization further leverage OUS #clinical data to comply with the #FDA’s updated IDE and PMA submission regulations? Join NAMSA tomorrow (April 17) for our complimentary webinar. To register, visit: https://t.co/p0gWEQlKMG #medtech https://t.co/zKss8aOTB3
Monday, April 15th, 2019 at 7:05am
With #IVDR mandatory compliance just nearly three years away, choosing the right-fit Notified Body for your #IVD product is crucial. Join NAMSA on April 30 for our webinar, “How to Select the Right EU Notified Body for IVDR Compliance.” https://t.co/apiz6B9Yw1 #EU https://t.co/7wsL1WNoUK
With #IVDR mandatory compliance just nearly three years away, choosing the right-fit Notified Body for your #IVD product is crucial. Join NAMSA on April 30 for our webinar, “How to Select the Right EU Notified Body for IVDR Compliance.” https://t.co/apiz6B9Yw1 #EU https://t.co/7wsL1WNoUK
Friday, April 12th, 2019 at 9:43am
Did you miss NAMSA at the MedTech Strategist Innovation Summit? Check out our other upcoming events: https://t.co/HWVpMFH3wp Our #medicaldevice development experts always welcome the opportunity to meet with you to discuss the most efficient pathways to market. https://t.co/WtRRvfLk8P
Did you miss NAMSA at the MedTech Strategist Innovation Summit? Check out our other upcoming events: https://t.co/HWVpMFH3wp Our #medicaldevice development experts always welcome the opportunity to meet with you to discuss the most efficient pathways to market. https://t.co/WtRRvfLk8P
Thursday, April 11th, 2019 at 8:42am
Join NAMSA at the Extractables and Leachables 2019 conference May 7-9, 2019. Joshua Young, PhD (Senior Study Director, NAMSA) will present a session on May 8 regarding solvent selection. Learn more: https://t.co/aMgOWZJLFb #medtech #medicaldevice #chemicalcharacterization https://t.co/r5kqWOMayL
Join NAMSA at the Extractables and Leachables 2019 conference May 7-9, 2019. Joshua Young, PhD (Senior Study Director, NAMSA) will present a session on May 8 regarding solvent selection. Learn more: https://t.co/aMgOWZJLFb #medtech #medicaldevice #chemicalcharacterization https://t.co/r5kqWOMayL
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 …