The European Union’s (EU) Medical Device Regulation (MDR), officially passed in April of 2017, may cause significant changes to the regulatory obligations of legal manufacturers, importers and distributors involved in …
Recent Articles
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 …
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 …
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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
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 …
EU MDR Poses Significant Changes for Importers and Distributors
The European Union’s (EU) Medical Device Regulation (MDR), officially passed in April of 2017, may cause significant changes to the regulatory obligations of legal manufacturers, importers and distributors involved in …
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 …