This Medical device training is a section-by-section review of ISO 13485 in a clear concise manner, and provides suggestions for development of a compliant system.
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.
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 seminar:
- The purpose of the standard.
- Standard structure.
- Requirements.
- 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
Course Provider
Jeff Kasoff,
