Risk management is a relatively young management concept. During the last ten to 15 years, it has evolved from a technical economic discipline with roots in insurance, finance and engineering …
Recent Articles
MDR Transition Timelines for Legacy Medical Devices – Not without Risks and Undue Burden
The approval of the new European (EU) Medical Device Directive (MDR) and EU In Vitro Diagnostic Regulation (IVDR) on April 5, 2017 by the EU Parliament in Strasburg, France has …
EU Parliament Votes to Institute the New IVDR and MDR Regulations; Transition Period Expected to Begin on June 1, 2017
The New EU Medical Devices Regulation (MDR) and In vitro Diagnostics Regulation (IVDR) were approved by the EU Parliament on April 5, 2017. The final regulations, expected to be published …
France Imposes New Registration Requirement for Implantable and Class III Medical Device Manufacturers
On December 13, 2016, the French Decree 2016-1716[1] implementing French Law 2016-41 and modernizing the French healthcare system[2] was adopted. This Decree provides important information concerning the obligation of manufacturers …
Planning for Success: UDI Requirements Under the EU MDD/MDR
A stunning new chapter opened up with the recast of the MDD (Medical Device Directive) which is to become MDR (Medical Device Regulation) legislation in Q3-2017, presumably. Several articles and …
Social Media
Monday, June 26th, 2017 at 10:31am
NAMSA to present FDA/CMS Parallel Review Process webinar with FDA's Ken Skodacek (Policy Analyst) on 7/18.
https://t.co/0TryGDXixK
NAMSA to present FDA/CMS Parallel Review Process webinar with FDA's Ken Skodacek (Policy Analyst) on 7/18.
https://t.co/0TryGDXixK
Thursday, June 22nd, 2017 at 10:35am
Register for our upcoming webinar on July 20: "Understanding Medical Device Regulatory Pathways in China and Japan" https://t.co/a65IwZtG2D https://t.co/3qFsUBZ4NE
Register for our upcoming webinar on July 20: "Understanding Medical Device Regulatory Pathways in China and Japan" https://t.co/a65IwZtG2D https://t.co/3qFsUBZ4NE
Wednesday, June 21st, 2017 at 1:22pm
Registration is now open for NAMSA's Biological Safety Training in Stuttgart, Germany (Oct. 9-12). https://t.co/2UWkIncimR #CRO #MRO https://t.co/ir9hsGKFsk
Registration is now open for NAMSA's Biological Safety Training in Stuttgart, Germany (Oct. 9-12). https://t.co/2UWkIncimR #CRO #MRO https://t.co/ir9hsGKFsk
Wednesday, June 21st, 2017 at 9:10am
Webinar: The Value of Preclinical Studies from Concept to Commercialization
7/13: https://t.co/CTLPSBFG6O
7/14: https://t.co/Fqb7kHjvwH https://t.co/k4WBfI7r12
Webinar: The Value of Preclinical Studies from Concept to Commercialization
7/13: https://t.co/CTLPSBFG6O
7/14: https://t.co/Fqb7kHjvwH https://t.co/k4WBfI7r12
Tuesday, June 20th, 2017 at 12:38pm
Registration now open for NAMSA's Biological Safety Training in Philadelphia (9/25-9/28)!
https://t.co/Au3Xx8BbqO https://t.co/2YWTTVipoa
Registration now open for NAMSA's Biological Safety Training in Philadelphia (9/25-9/28)!
https://t.co/Au3Xx8BbqO https://t.co/2YWTTVipoa
Monday, June 19th, 2017 at 9:13am
Join us @DeviceTalks on 6/27 (3-4 PM) to learn more about new developments in the world of reimbursement. https://t.co/wCIJJdNnu1 #CRO #MRO https://t.co/sYkevWev7d
Join us @DeviceTalks on 6/27 (3-4 PM) to learn more about new developments in the world of reimbursement. https://t.co/wCIJJdNnu1 #CRO #MRO https://t.co/sYkevWev7d
Trending Articles
2017 Medical Device Outlook: Five Potential Impacts to Global Device Organizations
During the course of the last several months, there have been many regulatory shifts surrounding medical device development throughout the globe. NAMSA’s experts, working with various government entities and regulatory …
Important Considerations for Labelling of Medical Devices Under the New EU MDR
The new European Medical Device Regulation (MDR) gives great importance to the information supplied by a manufacturer to the end user to assist with the safe and proper use of …
Risk: An Emerging Driver for New Regulatory Requirements
Risk management is a relatively young management concept. During the last ten to 15 years, it has evolved from a technical economic discipline with roots in insurance, finance and engineering …