How to Streamline Clinical Evaluation Reports for Medical Devices
In the ever-evolving landscape of medical device regulation, Clinical Evaluation Reports (CERs) play a pivotal role in ensuring compliance with the Medical Device Regulation (MDR). For Regulatory Affairs executives, the […]
IVDR in Focus: Tips for Performance Evaluation Planning to Support Your Transition from IVDD to IVDR
While the concept of a “performance evaluation” hasn’t changed much over the past two decades, IVDR requirements regarding the amount and extent of technical documentation have significantly changed compared to […]
Adapting to Regulatory Evolution- Pharma Writing Strategies for Changing Landscapes Introduction
The pharmaceutical industry is an arena marked by constant evolution, particularly in the realm of regulatory requirements. This dynamic environment, pivotal to global health, is under continuous scrutiny by regulatory […]
