Course Dates Upcoming Dates and Locations Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times. There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!
Course Details What Will You Learn At the end of this workshop, you will be able to: Describe the requirements of performance evaluation reports in the EU. Define clinical evidence, claims, and intended purpose statements and their relationship with each other. Describe performance evaluation plans and how they relate to performance evaluation reports. Describe the purpose of the scientific validity report and the information that should be included in it. Describe the objective of the analytical performance report and the data required to substantiate conclusions. Describe the purpose of the clinical performance report and the conclusions that can be drawn from it. Identify sources of clinical literature, search criteria, and state of the art with linkage to the PER. Explain equivalent device data and when it can be used. Demonstrate how data is appraised and analyzed, and the summarization of safety and performance. Discuss the benefit-risk analysis and how ISO 14971 is relevant to PERs. Explain postmarket surveillance and its relevance to PERs. Describe postmarket performance follow-up, procedures for collecting data, and the rationale for when it is needed. Illustrate the life-cycle approach to PERs and postmarket performance follow-up (PMPF). Define the characteristics of the PER’s summary and conclusion sections and the rationale for when updates may be made to PERs. Who Should Attend This course is appropriate for anyone working in regulatory, quality, postmarket surveillance, marketing, R&D, medical/clinical affairs, and those who need to create, review, and audit performance evaluation reports. Virtual Half-Days In-Person Full-Days CEUs 2.4