Designed to be educational, our white papers take a deep dive into important regulatory topics.
The Impact of COVID-19 on the Medical Device Regulation (MDR)
This white paper provides details on the impact COVID-19 has had on the implementation of the Medical Device Regulation (MDR), implications for medical device companies, and actionable steps companies can take to use this delay to position them for success.
Five Tips and Tricks: Developing a Comprehensive Performance Evaluation Plan (PEP)
Have a new in vitro diagnostic seeking approval? Transitioning a legacy device from compliance under IVDD to compliance under IVDR? Check out our tips and tricks for starting the performance evaluation process under EU Regulation 2017/746 (IVDR).