[FREE WEBINAR] Critical Concepts: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies
Click here to watch the recording of this webinar. In September 2022, European Commissioners published updates to the Manual on Borderline and Classification for Medical Devices, which provides clarifications for […]
[FREE WEBINAR] Critical Concepts: The Role of Post Market Activities in Establishing Data Sufficiency
Click here to watch the recording of this webinar. In this webinar, we review the conformity requirements for legacy devices under the MDR and established devices under the IVDR to […]
[FREE WEBINAR] CER Critical Concepts: Effectively Telling the Story of the CER – Focus on S&P Objectives, Acceptance Criteria, Clinical Benefits and Risk-Benefit Analysis
Click here to watch the recording of this webinar. Presented from the point of view of seasoned MDR-compliant CER medical writers, this session takes a practical approach to define safety […]
