This half-day course has been specifically designed to provide medical device industry executives and senior managers with the knowledge required to successfully oversee the implementation of ISO 13485, and to understand their role in this process ISO 13485 requires management at the most senior levels to determine the quality policies from which objectives should be developed, to communicate these to the relevant personnel and to ensure that these objectives are met.
Course Objectives:
To provide all participants with a sufficient understanding of all the clauses of ISO 13485 such that they can successfully oversee the implementation and maintenance of ISO 13485
To enable participants to apply the principles of ISO 13485, clause 5: Management responsibility
Who should attend:
Medical Device Industry Executives and Senior Management
Course Materials:
Participants will receive a comprehensive course manual with reference materials, and, upon successful completion of the course, a “certificate of attendance”.