This medical devices training seminar offers the opportunity to consider in depth BS EN ISO 13485:2003 and provides specific insight into its application within the medical device field. It adopts a practical approach to implementation at each tier of business processes, and features dedicated discussions of internal and external quality assessment and international regulation issues.
Agenda
Day 1
- Reasons for change: standards & regulation
- 8 quality management principles (ISO 9000:2008)
- Business management & regulatory importance
- Structure & content of BS EN ISO 13485:2003
- Quality Management Systems - general requirements, documentation & records
- Management responsibility
- Process mapping
- Resource management
Day 2
- Product realization
- Planning, design, development, purchasing, production
- Measurement and monitoring
- Measurement, analysis & improvement
- Transition and implementation strategy
- Internal quality auditing and EC directives
- Test (optional)
Format
This medical devices training seminar uses case studies and analysis of specific situations from real-life scenarios in typical medical device manufacturers.
Who should attend?
Anyone responsible for the design & manufacture of medical devices including:
- Senior Management
- Quality Assurance Professionals
- Internal & External Auditors
- Regulatory Professionals (Industry & Public Sector)
- Notified Body Auditors
- Product Designers & Operations Managers
Next steps
View our Medical Devices training course schedule.
For more information, please contact us or complete our enquiry form.
