Loading ...


Read More Courses
Read Less Courses
Course Dates Course Details Related Courses

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


Related Courses

Virtual Session Details

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

REQUEST A PROPOSAL Or ask a question!
Get answers right now. Call
us flag

US OfficeWashington DC


EU OfficeCork, Ireland

eu flag

+353 21 212 8530

© Oriel STAT A MATRIX. All Rights Reserved. Site Map Privacy and Legal