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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Tuesday, January 21st, 2020 at 1:45pm
From defining and prioritizing reports required for the EU MDR/IVDR to manuscript submissions and literature summaries, NAMSA's team of 45+ global medical writing experts are here to help support your development and commercialization efforts. Lean more: https://t.co/Lnf40fDIBw https://t.co/0u5ugRaEl7
From defining and prioritizing reports required for the EU MDR/IVDR to manuscript submissions and literature summaries, NAMSA's team of 45+ global medical writing experts are here to help support your development and commercialization efforts. Lean more: https://t.co/Lnf40fDIBw https://t.co/0u5ugRaEl7
Tuesday, January 21st, 2020 at 10:53am
Join NAMSA tomorrow (Jan. 22) for our latest webinar to gain a deeper understanding about how to determine if a device qualifies as SaMD, the challenges and opportunities of SaMD and more. https://t.co/oyM2Dnc4Rk #medtech #medicaldevice #samd #CRO #MRO https://t.co/fSvjLZs1o0
Join NAMSA tomorrow (Jan. 22) for our latest webinar to gain a deeper understanding about how to determine if a device qualifies as SaMD, the challenges and opportunities of SaMD and more. https://t.co/oyM2Dnc4Rk #medtech #medicaldevice #samd #CRO #MRO https://t.co/fSvjLZs1o0
Monday, January 20th, 2020 at 1:14pm
Join NAMSA for its upcoming webinar as we walk though strategies for effective utilization of ISO 10993-18:2020 to demonstrate proper safety evaluation and more. Register today: https://t.co/2Wr1WdAb9z #iso #biocompatibility #characterization #medtech #medicaldeivce #evaluation https://t.co/GupxtyFt3y
Join NAMSA for its upcoming webinar as we walk though strategies for effective utilization of ISO 10993-18:2020 to demonstrate proper safety evaluation and more. Register today: https://t.co/2Wr1WdAb9z #iso #biocompatibility #characterization #medtech #medicaldeivce #evaluation https://t.co/GupxtyFt3y
Friday, January 17th, 2020 at 8:06am
Join NAMSA on 25 Feb. for a workshop dedicated to best practices for meeting regulatory requirements for chemical characterization and characterization of materials and devices. Register today: https://t.co/PtinhFLMvr #FDA #MDR #EU #characterization #CRO #ISO https://t.co/KKg9dygSQy
Join NAMSA on 25 Feb. for a workshop dedicated to best practices for meeting regulatory requirements for chemical characterization and characterization of materials and devices. Register today: https://t.co/PtinhFLMvr #FDA #MDR #EU #characterization #CRO #ISO https://t.co/KKg9dygSQy
Wednesday, January 15th, 2020 at 8:01am
Join NAMSA on Feb. 19 for our latest webinar to gain a better understanding of IVDR QMS requirements, ISO 14971 and other critical components to achieve IVDR conformity.
https://t.co/3AdrhoY1Cp #EU #IVDR #QMS #ISO #CRO #regulatory https://t.co/Pw9xT6ajV9
Join NAMSA on Feb. 19 for our latest webinar to gain a better understanding of IVDR QMS requirements, ISO 14971 and other critical components to achieve IVDR conformity.
https://t.co/3AdrhoY1Cp #EU #IVDR #QMS #ISO #CRO #regulatory https://t.co/Pw9xT6ajV9
Tuesday, January 14th, 2020 at 10:48am
Join NAMSA and Baker McKenzie during the J.P. Morgan Healthcare Conference today for an interactive panel discussion designed to help attendees gain a strong understanding of #FDA and EMA issues, challenges faced by start-ups in the global market and more. https://t.co/3iiAtCYSBn https://t.co/s2rmeg0joS
Join NAMSA and Baker McKenzie during the J.P. Morgan Healthcare Conference today for an interactive panel discussion designed to help attendees gain a strong understanding of #FDA and EMA issues, challenges faced by start-ups in the global market and more. https://t.co/3iiAtCYSBn https://t.co/s2rmeg0joS
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 …
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 …
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 …