Clinical Evaluation Plan and Report
The request and requirements on clinical evaluations has increased over the years and it will not become less with the coming new Medical Device Regulation. This course will focus on the standards and guidance given, how to make a literature search and plan for clinical evaluation, the report and the feedback system.
About Clinical Evaluation Plan and Report
Goal:
To give an understanding of the process to run clinical evaluations and how to keep the evaluation up to date during the life cycle of a medical device.
Who benefits:
Clinical affairs, QA/RA specialists, risk managers, marketing.
Course Leader:
Anette Sjögren, PREVENTIA AB
Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force.
Language:
Course material is in English.
Presentation in English or Swedish (depending on the participants).
About Clinical Evaluation Plan and Report
Goal:
To give an understanding of the process to run clinical evaluations and how to keep the evaluation up to date during the life cycle of a medical device.
Who benefits:
Clinical affairs, QA/RA specialists, risk managers, marketing.
Course Leader:
Anette Sjögren, PREVENTIA AB
Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force.
Language:
Course material is in English.
Presentation in English or Swedish (depending on the participants).