Human factors principles have long been applied in high-hazard industries such as aerospace, nuclear, petrochemical, energy and transport in an effort to minimize potential risks. Increasingly, human factors in the …
Recent Articles
UK MHRA Publishes Guide to the New EU Medical Device and IVD Regulations
On August 29, 2017, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published an interactive guide to assist Medical Device and In Vitro Diagnostics (IVD) companies with a …
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 …
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 …
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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
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 …
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 …
Medical Device Clinical Trials: SAE reporting requirements in Germany and Austria
For Combination Products, the intended use and mode of action is the deciding criterion whether the study is regulated by the MDD (93/42/EEC; 2007/47/EC)/AIMDD (90/385/EEC; 2007/47/EC) or the MPD (2001/83/EC; …