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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Join NAMSA for its highly sought-after training series in San Diego on Jan. 27-30. Learn about the practical use of #biocompatibility planning & implementation, risk assessments and more. Early-bird registration ends Dec. 31, 2019. https://t.co/PS4YifFFAv #CRO #MRO #FDA #ISO https://t.co/VZ2w2QjVCH

Have you checked out NAMSA's “Biocompatibility Strategy Navigator” yet? Access this first-of-its-kind online resource to help your organization simplify the process of identifying #biological endpoint assessments for intended global #regulatory pathways: https://t.co/j1wtuR9fCn https://t.co/L9VxrbYRwY

Want to expand your knowledge of the medical device industry but don’t have the time to travel to a conference? Check out NAMSA’s e-Learning courses today! https://t.co/bEY5IHLCOC #medicaldevice #medtech #MRO #CRO https://t.co/TML45fzAwO

On September 20, 2019, #FDA issued a new draft guidance with the intent to reduce the regulatory burden on the #medicaldevice industry through consensus of efficiency requirements. Learn more: https://t.co/zsRUTv0cG8 #CRO #MRO #medtech #premarketapproval #CDRH #CBER https://t.co/0sy163tzrb

Listen in on NAMSA’s latest BiocompCHATibility podcast episode, where our hosts, joined with Dr. Jean Pierre Boutrand, discuss the new, second edition of “Biocompatibility and Performance of Medical Devices.” https://t.co/NFenNrNZCN #biocompatibility #medicaldevice #medtech #CRO https://t.co/pY8FCuiGoh

Join NAMSA tomorrow, December 3, for our webinar, “The Biological Evaluation Plan: How Can a Step-Wise Approach Create Resource Efficiencies?” Discussed will be how to define a plan to ensure #biologicalsafety and more. https://t.co/VlxSVsj2GU #fda #medtech #cro https://t.co/bn2r0DYBn6

Trending Articles
China Acceptance of Foreign Biocompatibility Reports
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 …
Moving From In Vitro to In Vivo: What Happens Next?
Preclinical testing of an investigational medical device is a necessary step in obtaining market approval from regulatory agencies. The purpose of preclinical testing is to establish the safety of a …
New Developments in FDA Biocompatibility Requirements for Personal Lubricants
Personal lubricants are a lucrative portion of the medical device market in the US and elsewhere. In the past, the Food and Drug Administration (FDA) has considered them to be …