A medical device company practical guide to the PMCF requirements of the EU MDRThe European Medical Device Regulation (EU MDR) deadlines are closing in for re-certification and/or introduction of new products. This…Jan 14, 2022Jan 14, 2022
What is the difference between GMP, FDA, DMF, ISO, and CEP?What is GMP (Good Manufacturing Practices)?Dec 15, 2021Dec 15, 2021
Myths about ISO 14971 Certification and Medical Device Risk ManagementFor more than 20 years, ISO 14971 has been the international standard for managing medical device risks. The standard is essential if you…Nov 27, 2021Nov 27, 2021
5 Best Clinical Evaluation Report Writing TipsThe EU MDR has a significant impact on the manner in which medical devices are regulated in Europe. To ensure compliance with the…Sep 29, 2021Sep 29, 2021
