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, December 7th, 2018 at 8:46am
Just Announced! #FDA opens comment period for medical device De Novo classification process requirements. Learn more: https://t.co/QKxDFEmR3w #denovo #PMA #CDRH #regulatory #medicaldevice #medtech https://t.co/5Ik9STIZYj
Just Announced! #FDA opens comment period for medical device De Novo classification process requirements. Learn more: https://t.co/QKxDFEmR3w #denovo #PMA #CDRH #regulatory #medicaldevice #medtech https://t.co/5Ik9STIZYj
Monday, December 3rd, 2018 at 6:01am
Listen to NAMSA’s latest recorded webinar to review major changes and testing strategies to efficaciously prepare for implementation (presented by biological safety expert, Don Pohl). Access here: https://t.co/6uzPk6BYBo #ISO #biologicalsafety https://t.co/GTgV5Po6mO
Listen to NAMSA’s latest recorded webinar to review major changes and testing strategies to efficaciously prepare for implementation (presented by biological safety expert, Don Pohl). Access here: https://t.co/6uzPk6BYBo #ISO #biologicalsafety https://t.co/GTgV5Po6mO
Friday, November 30th, 2018 at 6:02am
NAMSA Training Series offers industry-leading educational programs that provide expertise and insight into critical medical device topics (certifications available). Register today! https://t.co/vNBLPkitB3 #medtech #medicaldevice #biologicalsafety https://t.co/8EULMvAuhE
NAMSA Training Series offers industry-leading educational programs that provide expertise and insight into critical medical device topics (certifications available). Register today! https://t.co/vNBLPkitB3 #medtech #medicaldevice #biologicalsafety https://t.co/8EULMvAuhE
Thursday, November 29th, 2018 at 8:02am
Have you accessed NAMSA’s 2018 “Medical Device Landscape Report: Trends & Challenges in Clinical Research Outsourcing” yet? Download your copy today! https://t.co/hZtkkd6vC6 #clinical #medicaldevice #medtech #CRO https://t.co/aJAQOEkZqo
Have you accessed NAMSA’s 2018 “Medical Device Landscape Report: Trends & Challenges in Clinical Research Outsourcing” yet? Download your copy today! https://t.co/hZtkkd6vC6 #clinical #medicaldevice #medtech #CRO https://t.co/aJAQOEkZqo
Wednesday, November 28th, 2018 at 11:29am
On Nov. 26, the #FDA issued proposed changes to the agency’s 510(k) program, including updated criteria for U.S. manufacturers seeking approval via predicate devices. What do these changes mean for industry? Read more:
https://t.co/XfMnQijpOB https://t.co/tmhgdE02fW
On Nov. 26, the #FDA issued proposed changes to the agency’s 510(k) program, including updated criteria for U.S. manufacturers seeking approval via predicate devices. What do these changes mean for industry? Read more:
https://t.co/XfMnQijpOB https://t.co/tmhgdE02fW
Wednesday, November 21st, 2018 at 6:00am
NAMSA invites you to join us at the Q1 Productions 11th Annual IVD Regulatory Affairs Conference in Alexandria, VA on December 5-6. Learn more: https://t.co/Z3AbgLyHCS #IVD #IVDR #medtech https://t.co/A2FGszwtQh
NAMSA invites you to join us at the Q1 Productions 11th Annual IVD Regulatory Affairs Conference in Alexandria, VA on December 5-6. Learn more: https://t.co/Z3AbgLyHCS #IVD #IVDR #medtech https://t.co/A2FGszwtQh
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 …