This session's topic: The Performance Evaluation Report (PER) With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. What challenges are you or your team currently facing? Which areas do you need performance evaluation report guidance? During this 45-minute Q&A session, our […]
This session's topic: The Performance Evaluation Report (PER) With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. What challenges are you or your team currently facing? Which areas do you need performance evaluation report guidance? During this 45-minute Q&A session, our […]
This session's topic: Safety and Performance Measures and Acceptance Criteria Do you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance? During this 45-minute Q&A session, our President Laurie Mitchell answers questions on how to identify […]
