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 …
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Friday, August 16th, 2019 at 11:05am
Join NAMSA at the upcoming Medical Alley Innovation Summit in Minneapolis in September! Our medical device development experts will also be available throughout the summit for complimentary consultations. https://t.co/BGW25LT2aK #medtech #medicaldevice #CRO #MRO https://t.co/rd1fytYGOY
Join NAMSA at the upcoming Medical Alley Innovation Summit in Minneapolis in September! Our medical device development experts will also be available throughout the summit for complimentary consultations. https://t.co/BGW25LT2aK #medtech #medicaldevice #CRO #MRO https://t.co/rd1fytYGOY
Thursday, August 15th, 2019 at 11:00am
Join NAMSA on September 4 for the webinar, “Impacts of the Updated ISO 14971 & Harmonization of MDR/FDA Rules on Risk Management,” presented by Linda Mummah-Schendel and Rich Granquist. Register today: https://t.co/cSWuYtsdhG #medtech #medicaldevice #regulatory #CRO #FDA #MDR https://t.co/m95vV6Yzrr
Join NAMSA on September 4 for the webinar, “Impacts of the Updated ISO 14971 & Harmonization of MDR/FDA Rules on Risk Management,” presented by Linda Mummah-Schendel and Rich Granquist. Register today: https://t.co/cSWuYtsdhG #medtech #medicaldevice #regulatory #CRO #FDA #MDR https://t.co/m95vV6Yzrr
Thursday, August 15th, 2019 at 6:01am
Join NAMSA’s regulatory experts, as well as Erica Conway from BSI, to learn suggested strategies and best practices to efficiently navigate the UK’s unique medical device development landscape. https://t.co/NmJ7rgqxB5 #IVDR #IVD #Brexit #CRO https://t.co/M8MiEYbzRV
Join NAMSA’s regulatory experts, as well as Erica Conway from BSI, to learn suggested strategies and best practices to efficiently navigate the UK’s unique medical device development landscape. https://t.co/NmJ7rgqxB5 #IVDR #IVD #Brexit #CRO https://t.co/M8MiEYbzRV
Wednesday, August 14th, 2019 at 9:39am
Access NAMSA's latest white paper, “Medical Device Biological Evaluation Reports: Relevance to the Revised ISO 10993-Part 1: 2018,” to better understand how to properly address the updated requirements within evaluation reports. https://t.co/0WLAXxH6co #biologicalsafety #medtech https://t.co/PsrJgFrD7K
Access NAMSA's latest white paper, “Medical Device Biological Evaluation Reports: Relevance to the Revised ISO 10993-Part 1: 2018,” to better understand how to properly address the updated requirements within evaluation reports. https://t.co/0WLAXxH6co #biologicalsafety #medtech https://t.co/PsrJgFrD7K
Wednesday, August 7th, 2019 at 8:31am
NAMSA’s highly sought-after educational programs provide insight into critical medical device development topics. Led by our CRO development experts, courses are interactive to promote engagement between attendees and industry thought leaders. Learn more: https://t.co/yQ3XFGbJj1 https://t.co/JColD9vvHA
NAMSA’s highly sought-after educational programs provide insight into critical medical device development topics. Led by our CRO development experts, courses are interactive to promote engagement between attendees and industry thought leaders. Learn more: https://t.co/yQ3XFGbJj1 https://t.co/JColD9vvHA
Monday, August 5th, 2019 at 9:47am
Unlike other industry events focused on #MDR, this hands-on training will be led by Notified Body expert, Adrian Keene (former Head of SGS and Technical Manager at LRQA). Sort through MDR regulatory components to understand what is really required: https://t.co/PKnqA9gaI5 https://t.co/dvmwzOduBB
Unlike other industry events focused on #MDR, this hands-on training will be led by Notified Body expert, Adrian Keene (former Head of SGS and Technical Manager at LRQA). Sort through MDR regulatory components to understand what is really required: https://t.co/PKnqA9gaI5 https://t.co/dvmwzOduBB
Trending Articles
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, …
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 …
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 …