Clinical Evaluation (in English)
The course focus on process related to legislative requirements. Overview of clinical evaluation approach, principles and requirements related to new requirements and legislative.
Background
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 part of 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.Scope
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.
Intended for:
Clinical QA/RA specialists, risk managers, management, design&development engineers, customer support/service and 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) commitee and was also part of the international PMS task force.Language:
Course material is in English, presentation in EnglishNote: Czech VAT will be applied for all participants.
Background
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 part of 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.Scope
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.
Intended for:
Clinical QA/RA specialists, risk managers, management, design&development engineers, customer support/service and 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) commitee and was also part of the international PMS task force.Language:
Course material is in English, presentation in EnglishNote: Czech VAT will be applied for all participants.