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
Monday, December 9th, 2019 at 7:32am
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
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
Friday, December 6th, 2019 at 6:31am
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
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
Thursday, December 5th, 2019 at 8:17am
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
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
Wednesday, December 4th, 2019 at 9:05am
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
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
Tuesday, December 3rd, 2019 at 8:11am
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
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
Monday, December 2nd, 2019 at 8:21am
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
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 …