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, February 22nd, 2019 at 8:00am
Are you an early-stage #medicaldevice firm? There is still time to register for NAMSA's complimentary Start-Up Summit on February 28 to learn proven strategies for efficient, cost-effective product development. https://t.co/zXmrNqlwRN #reimbursement #MRO #CRO #medtech https://t.co/9OXgWYUMho
Are you an early-stage #medicaldevice firm? There is still time to register for NAMSA's complimentary Start-Up Summit on February 28 to learn proven strategies for efficient, cost-effective product development. https://t.co/zXmrNqlwRN #reimbursement #MRO #CRO #medtech https://t.co/9OXgWYUMho
Friday, February 22nd, 2019 at 4:00am
Join NAMSA at the 11th Annual EU Medical Device Clinical Research Conference in Berlin, Germany. Our #medicaldevice development experts will be available throughout the conference for complimentary consultations. Learn more: https://t.co/mUZHFpWRid #clinical #medtech #regulatory https://t.co/P24rbbMnCN
Join NAMSA at the 11th Annual EU Medical Device Clinical Research Conference in Berlin, Germany. Our #medicaldevice development experts will be available throughout the conference for complimentary consultations. Learn more: https://t.co/mUZHFpWRid #clinical #medtech #regulatory https://t.co/P24rbbMnCN
Thursday, February 21st, 2019 at 12:19pm
Join NAMSA on March 20 for our latest webinar, “Design Control: Understanding the Benefits of Starting Early and Why it’s Necessary,” presented by Linda Mummah-Schendel (Principal Quality Consultant, NAMSA). https://t.co/YdZdlY3ET4 #quality #medicaldevice #medtech #MRO #CRO https://t.co/rUcvqX0icZ
Join NAMSA on March 20 for our latest webinar, “Design Control: Understanding the Benefits of Starting Early and Why it’s Necessary,” presented by Linda Mummah-Schendel (Principal Quality Consultant, NAMSA). https://t.co/YdZdlY3ET4 #quality #medicaldevice #medtech #MRO #CRO https://t.co/rUcvqX0icZ
Wednesday, February 20th, 2019 at 11:04pm
NAMSA invites you to meet with us at MedTec Japan in Tokyo, Japan on 18-20 March. Stop by booth #813 for a complimentary consultation or schedule an appointment with us ahead of time. Learn more: https://t.co/FZ2oKHndKg #medicaldevice #medtech #CRO #MRO #biologicalsafety https://t.co/2fQwMTh6eC
NAMSA invites you to meet with us at MedTec Japan in Tokyo, Japan on 18-20 March. Stop by booth #813 for a complimentary consultation or schedule an appointment with us ahead of time. Learn more: https://t.co/FZ2oKHndKg #medicaldevice #medtech #CRO #MRO #biologicalsafety https://t.co/2fQwMTh6eC
Wednesday, February 20th, 2019 at 8:05am
Join NAMSA on Feb. 28 in Minneapolis, MN for our complimentary Start-Up Summit, a unique event that will provide early-stage #medicaldevice organizations with best practices and guidance for product development, #FDA trends and reimbursement. https://t.co/sJuQDFDj2E #medtech #CRO https://t.co/Q9Ahf1LMNG
Join NAMSA on Feb. 28 in Minneapolis, MN for our complimentary Start-Up Summit, a unique event that will provide early-stage #medicaldevice organizations with best practices and guidance for product development, #FDA trends and reimbursement. https://t.co/sJuQDFDj2E #medtech #CRO https://t.co/Q9Ahf1LMNG
Wednesday, February 20th, 2019 at 5:03am
With EU Medical Device Regulation (MDR) compliance timeframes quickly approaching, the pressure of implementing transition plans for #medicaldevice manufactures is increasing. Join NAMSA on 28 March 2019 for our #MDR Summit in Aachen, Germany. https://t.co/o8zY6k3xzm #regulatory https://t.co/HTgRhG6T4D
With EU Medical Device Regulation (MDR) compliance timeframes quickly approaching, the pressure of implementing transition plans for #medicaldevice manufactures is increasing. Join NAMSA on 28 March 2019 for our #MDR Summit in Aachen, Germany. https://t.co/o8zY6k3xzm #regulatory https://t.co/HTgRhG6T4D
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 …