This course is designed to provide participants with an understanding of the risk classification criteria for medical devices of the EU Medical Devices Directives, to prepare medical device organizations to unannounced audits.
Objectives
Gain an understanding of the reclassification of new and/or existing medical devices according to the classification criteria of EU Medical Devices Directives. The course will provide the tools to medical device organizations to undergo unannounced audits
Inteded Audience
- The course is especially designed for medical device manufacturers and all the personnel involved in design and classification of medical devices (QA, DD, RA etc.)
- All those that are involved in the unannounced audits (AQ,RA,etc.)
- Regulatory, quality, design, development, manufacturing, marketing managers and personnel.
Prerequisites
Participants should have experience with or basic knowledge of quality management systems for the medical device industry. Recommended is a basic awareness of medical devices, quality assurance, and ISO 13485.
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