EU MDR

The new EU MDR Regulations Everything you needed to know in 2020 The final period for compliance with EU medical device regulation…

In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof of and document the performance and safety of…

Introduction Clinical trials are a fundamental component of medical product development, providing a controlled environment to evaluate the safety and performance of…

Clinical trials are a crucial piece of launching a medical device. Publishing the data you have gathered regarding the safety and effectiveness…

Implementing the MDR or Medical Device Regulation will bring significant changes to the process of Clinical Evaluation and subsequent post-market compliance requirements.…

A strong CER medical writer combines the right academic background, real regulatory experience, and precise technical writing, and meets the specific qualification…

Introduction to Software as a Medical Device in MDR The MDCG's Guidance document defines the criteria for software qualification falling within the…

Yes, most manufacturers do. They write PMCF studies, surveys, and monitoring frequencies into their PMS plan and CER that they don't have…