Development, implementation, and maintenance of an ISO 13485-compliant quality management system requires many resources and personnel to meet with success.
ISO 13485 is a wordy standard, drafted by individuals for many of whom English is not their primary language. This webinar is a section-by-section review of ISO 13485 in a clear concise manner, and provides suggestions for development of a compliant system.
Areas Covered in the Session:
- The purpose of the standard
- The structure of the standard
- The requirements of the standard
- Straightforward recommended implementation approach
Who Will Benefit:This webinar will provide valuable assistance to all device manufacturers who wish to have a better understanding of the requirements of ISO 13485. The employees who will benefit include:
- Top management
- Regulatory Management
- Quality Management
- Documentation Managers
- Quality Engineers
- Other personnel involved in development and implementation of the QMS