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, October 13th, 2017 at 8:35am
Join NAMSA for our highly sought-after Biological Safety Training series in San Diego on Jan. 29-Feb. 1, 2018. https://t.co/U1tpaipMXk #CRO https://t.co/gwALx8XkfH
Join NAMSA for our highly sought-after Biological Safety Training series in San Diego on Jan. 29-Feb. 1, 2018. https://t.co/U1tpaipMXk #CRO https://t.co/gwALx8XkfH
Wednesday, October 11th, 2017 at 9:27am
Thank you to our Associates who donated new and gently used winter gear for Twin Cities residents. To donate, visit: https://t.co/1WWVPNh2aU https://t.co/iem4mklXE7
Thank you to our Associates who donated new and gently used winter gear for Twin Cities residents. To donate, visit: https://t.co/1WWVPNh2aU https://t.co/iem4mklXE7
Wednesday, October 11th, 2017 at 9:06am
How are newly-released reg requirements addressing #patientsafey? NAMSA #blog post: https://t.co/XGwNKCDXB8 @NAMSA_MRO #humanfactors #CRO https://t.co/g847VMrYa0
How are newly-released reg requirements addressing #patientsafey? NAMSA #blog post: https://t.co/XGwNKCDXB8 @NAMSA_MRO #humanfactors #CRO https://t.co/g847VMrYa0
Monday, October 9th, 2017 at 11:28am
Are you a medical device firm located in Southern California? Join NAMSA tonight for our special networking happy hour! #medicaldevices https://t.co/O2S4SGkU6G
Are you a medical device firm located in Southern California? Join NAMSA tonight for our special networking happy hour! #medicaldevices https://t.co/O2S4SGkU6G
Friday, October 6th, 2017 at 8:16am
Thank you, NAMSA Associates! With your help, we raised nearly $4,500 for Hurricane Harvey relief. #giveback
https://t.co/4DCsF4hn7B https://t.co/2QSPmFeuZU
Thank you, NAMSA Associates! With your help, we raised nearly $4,500 for Hurricane Harvey relief. #giveback
https://t.co/4DCsF4hn7B https://t.co/2QSPmFeuZU
Thursday, October 5th, 2017 at 6:48am
NAMSA’s MRO® Approach Accelerates PMA Submission Timeline by 23 Months for Global Biosurgical Firm
https://t.co/NyIHShUoZF #medicaldevice https://t.co/fWYwVObRhr
NAMSA’s MRO® Approach Accelerates PMA Submission Timeline by 23 Months for Global Biosurgical Firm
https://t.co/NyIHShUoZF #medicaldevice https://t.co/fWYwVObRhr
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 …