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, June 14th, 2018 at 9:30am
Limited Seating Event! Don’t miss the inaugural North American Biocompatibility Summit (NABS), an exclusive event that will provide industry insights and expertise on the #biocompatibility of medical devices. Register today: https://t.co/k2sjrzoHuE #medtech @PaceLabs https://t.co/dFwfz7jdpF
Limited Seating Event! Don’t miss the inaugural North American Biocompatibility Summit (NABS), an exclusive event that will provide industry insights and expertise on the #biocompatibility of medical devices. Register today: https://t.co/k2sjrzoHuE #medtech @PaceLabs https://t.co/dFwfz7jdpF
Thursday, June 14th, 2018 at 6:22am
Complimentary Webinar | July 26 | 10-11 AM ET U.S. | Join us for a discussion on new and modified methods for irradiation #sterilization, validation strategies for the design and manufacture of low/high bioburden devices, and more. https://t.co/aqXZ5aCesN #medtech #medicaldevice https://t.co/tTzVJJEFJL
Complimentary Webinar | July 26 | 10-11 AM ET U.S. | Join us for a discussion on new and modified methods for irradiation #sterilization, validation strategies for the design and manufacture of low/high bioburden devices, and more. https://t.co/aqXZ5aCesN #medtech #medicaldevice https://t.co/tTzVJJEFJL
Wednesday, June 13th, 2018 at 5:35am
Last chance! NAMSA’s global Biological Safety experts will present a training series on June 25-27 in Israel discussing best practices, proven strategies, and more. Make sure you’re set up for #medicaldevice development success! https://t.co/58eg5nUhGI #MRO #CRO #medtech https://t.co/xcY2Qqm9VR
Last chance! NAMSA’s global Biological Safety experts will present a training series on June 25-27 in Israel discussing best practices, proven strategies, and more. Make sure you’re set up for #medicaldevice development success! https://t.co/58eg5nUhGI #MRO #CRO #medtech https://t.co/xcY2Qqm9VR
Tuesday, June 12th, 2018 at 8:06am
NAMSA’s Contract Research Organization #CRO) services are designed around one goal: achieving client success. Our testing, clinical and consulting experts respond quickly to provide exceptional service. Learn more: https://t.co/yufvcjeAOz #medtech #medicaldevice #MRO https://t.co/PXaovU4kha
NAMSA’s Contract Research Organization #CRO) services are designed around one goal: achieving client success. Our testing, clinical and consulting experts respond quickly to provide exceptional service. Learn more: https://t.co/yufvcjeAOz #medtech #medicaldevice #MRO https://t.co/PXaovU4kha
Monday, June 11th, 2018 at 9:05am
NAMSA Blog Post: #FDA Issues Draft Guidance for Pre-Submissions; Some Feedback Timelines Reduced from 70 Days to 21. Learn more about how this could impact your regulatory business operations: https://t.co/dYBrWlrvjH #medtech #medicaldevice #MRO #CRO https://t.co/0B65T7pyLt
NAMSA Blog Post: #FDA Issues Draft Guidance for Pre-Submissions; Some Feedback Timelines Reduced from 70 Days to 21. Learn more about how this could impact your regulatory business operations: https://t.co/dYBrWlrvjH #medtech #medicaldevice #MRO #CRO https://t.co/0B65T7pyLt
Monday, June 11th, 2018 at 6:32am
Complimentary Webinar | July 12 | 10-11 AM ET U.S. | NAMSA invites you to our online event that will discuss #FDA chemical characterization requirements and how these may be utilized to cost-effectively assess patient impact and biological safety. https://t.co/YrxPoCM6vy #medtech https://t.co/UlMVu9pHP2
Complimentary Webinar | July 12 | 10-11 AM ET U.S. | NAMSA invites you to our online event that will discuss #FDA chemical characterization requirements and how these may be utilized to cost-effectively assess patient impact and biological safety. https://t.co/YrxPoCM6vy #medtech https://t.co/UlMVu9pHP2
Trending Articles
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, …
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 …
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 …