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, August 17th, 2017 at 10:50am
Discounted pricing for NAMSA's Biological Safety Training in Germany ends soon (Aug. 28)! Register today: https://t.co/Cogr3oLabU #CRO https://t.co/4dVBRtqizC
Discounted pricing for NAMSA's Biological Safety Training in Germany ends soon (Aug. 28)! Register today: https://t.co/Cogr3oLabU #CRO https://t.co/4dVBRtqizC
Wednesday, August 16th, 2017 at 9:51am
#Blog post: Japan’s #PMDA Consultation Offering-A Beneficial Resource for Streamlined Device Approval: https://t.co/TsOXZsKd3Z #CRO #MRO https://t.co/dUVU71NrbW
#Blog post: Japan’s #PMDA Consultation Offering-A Beneficial Resource for Streamlined Device Approval: https://t.co/TsOXZsKd3Z #CRO #MRO https://t.co/dUVU71NrbW
Tuesday, August 15th, 2017 at 9:22am
Less than a month away! Join NAMSA for its inaugural MRO Summit in Israel on Sept. 13! https://t.co/Ge1CepL2c6 https://t.co/QdU5U1pwEa
Less than a month away! Join NAMSA for its inaugural MRO Summit in Israel on Sept. 13! https://t.co/Ge1CepL2c6 https://t.co/QdU5U1pwEa
Monday, August 14th, 2017 at 9:01am
Schedule your free consultation with NAMSA @RAPSorg Regulatory Conference on Sept. 10-12 in National Harbor, MD: https://t.co/A80oz1il0O https://t.co/3R2dPe3dLk
Schedule your free consultation with NAMSA @RAPSorg Regulatory Conference on Sept. 10-12 in National Harbor, MD: https://t.co/A80oz1il0O https://t.co/3R2dPe3dLk
Wednesday, August 2nd, 2017 at 10:28am
Join NAMSA @MedTechMonday on Aug. 7 in Irvine, CA and meet with our experts for a complimentary consultation: https://t.co/LrLrXQQfmF https://t.co/sMgB4fejME
Join NAMSA @MedTechMonday on Aug. 7 in Irvine, CA and meet with our experts for a complimentary consultation: https://t.co/LrLrXQQfmF https://t.co/sMgB4fejME
Tuesday, August 1st, 2017 at 9:27am
NAMSA-Germany presents, "IVDR - How Can Medical Device Manufacturers Prepare for Success?" on Sept. 12 https://t.co/sIQj8uZS1m https://t.co/zgsd6JpnxQ
NAMSA-Germany presents, "IVDR - How Can Medical Device Manufacturers Prepare for Success?" on Sept. 12 https://t.co/sIQj8uZS1m https://t.co/zgsd6JpnxQ
Trending Articles
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 …
A Recent Human Anatomic Study Conducted with NAMSA
One of our clients recently conducted a human anatomic study to evaluate the deployment of percutaneous aortic valves. The study utilized whole-body cadaveric specimens and a pressurized flow circuit to …
Evaluation of Tissue Regeneration as Support in Translative Research
Due to ethical and moral considerations, translational research relies on the use of test models to approximate human wound healing in order to predict therapeutic outcomes. Efficient translation of basic …