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.
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
Instructor Profile:
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.
