EN ISO 13485:2016
The Management System EN ISO 13485:2016 defines quality management system standards for companies involved in one- or more stages of the medical device product cycle. Affected design and development, production, storage and sales, installation and maintenance of medical devices. Also, the departments design, development and provision of related operations (e.g. technical support) are concerned.
Topics:
- Alterations in EN ISO 13485
- Consequences of modified requirements on the Management System
- Exchange within the group and recommendation for action
Authorities affected by the alterations of EN ISO 13485: Chief Executives as well as Specialists and Managers of the medical device industry, particularly departments of Research and Development, Quality and Regulatory Affairs, Safety and Production, Marketing, Sales & Product Management, Maintenance, Technical Management and Technical Support; Medical Engineers of institutions within the healthcare sector, Distributors of medical products and Procurement Departments for medical products.
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