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, April 19th, 2018 at 10:00am
NAMSA’s world-class Contract Research Organization (CRO) services are designed around one goal: achieving client success. Learn what just a few of our clients are saying: https://t.co/rXAbQvTE43 #medtech #medicaldevice #CRO #MRO https://t.co/bViGwWfc27
NAMSA’s world-class Contract Research Organization (CRO) services are designed around one goal: achieving client success. Learn what just a few of our clients are saying: https://t.co/rXAbQvTE43 #medtech #medicaldevice #CRO #MRO https://t.co/bViGwWfc27
Thursday, April 19th, 2018 at 7:02am
Last chance to register! Join NAMSA for a discussion on CFDA’s recent regulatory amendments surrounding criteria for the submission of overseas clinical study data and clinical evaluation pathways. https://t.co/gRAQ7yOvHs #CFDA #medicaldevice #medtech https://t.co/Z9e0DkPVTb
Last chance to register! Join NAMSA for a discussion on CFDA’s recent regulatory amendments surrounding criteria for the submission of overseas clinical study data and clinical evaluation pathways. https://t.co/gRAQ7yOvHs #CFDA #medicaldevice #medtech https://t.co/Z9e0DkPVTb
Wednesday, April 18th, 2018 at 5:01am
Last chance! Sign up for NAMSA’s complimentary Medical Device Summit on 24 April in Leeds, UK! Register today: https://t.co/PcqkNs55lZ #medtech #EU #UK #medicaldevice #MDR https://t.co/f4HMlAHnYT
Last chance! Sign up for NAMSA’s complimentary Medical Device Summit on 24 April in Leeds, UK! Register today: https://t.co/PcqkNs55lZ #medtech #EU #UK #medicaldevice #MDR https://t.co/f4HMlAHnYT
Tuesday, April 17th, 2018 at 8:00am
New NAMSA Training Series: April 24-25 (Minneapolis, MN). Don’t miss out on this unique opportunity to learn from the medical device industry’s key opinion leaders. More information can be found at: https://t.co/zhbDEBONgv #medicaldevice #medtech #regulatory #EU #MDR https://t.co/j9u2EufxFW
New NAMSA Training Series: April 24-25 (Minneapolis, MN). Don’t miss out on this unique opportunity to learn from the medical device industry’s key opinion leaders. More information can be found at: https://t.co/zhbDEBONgv #medicaldevice #medtech #regulatory #EU #MDR https://t.co/j9u2EufxFW
Monday, April 16th, 2018 at 1:04pm
Attending MEDTEC Japan? Don’t miss the opportunity to meet with NAMSA’s medical device development experts for a complimentary consultation. Stop by Booth #1014, or simply click the link below to sign up. https://t.co/6lYUOTD0QW @MEDTECJapan1 #PMDA #medtech #medicaldevice https://t.co/2AI963H9KS
Attending MEDTEC Japan? Don’t miss the opportunity to meet with NAMSA’s medical device development experts for a complimentary consultation. Stop by Booth #1014, or simply click the link below to sign up. https://t.co/6lYUOTD0QW @MEDTECJapan1 #PMDA #medtech #medicaldevice https://t.co/2AI963H9KS
Friday, April 13th, 2018 at 10:03am
Join NAMSA at EuroPCR! Our experts will be available for 30-minute complimentary consultations to discuss with you the most cost-effective pathways to market based on your unique medical device requirements. https://t.co/ItUiUDJHAe #medtech #medicaldevice #Europe https://t.co/LHFRZZHWwU
Join NAMSA at EuroPCR! Our experts will be available for 30-minute complimentary consultations to discuss with you the most cost-effective pathways to market based on your unique medical device requirements. https://t.co/ItUiUDJHAe #medtech #medicaldevice #Europe https://t.co/LHFRZZHWwU
Trending Articles
Infographic: Common Mistakes in the Medical Device Development Continuum
Getting a medical device to market is a long process made up of multiple stages. Each stage requires a number of elements that need to be considered before progress can …
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 …
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 …