This one day course has been designed to provide an insight into the use of ISO 13485:2016 as the basis for a quality management system implemented by medical device manufacturers.
Time will be spent during the course exploring the requirements of ISO 13485:2016 and how the standard interacts with ISO 9001:2015, the European Medical Device Directive and the US FDA’s Quality System Regulation. In addition to this, participants will also gain an awareness of the relationship between ISO 13485:2016 and ISO 14971, Application of Risk Management to Medical Devices.
Who should attend?
- Senior Management
- Quality Managers
- Regulatory Affairs Managers
- Internal and external Auditors
- Anyone involved with the implementation of the standard
What will I learn?
On completion of this training, participants will be able to:
- Use ISO 13485:2016 as the basis for a QMS for medical device manufacturers
- Understand the relationship between ISO 13485:2016 and European Medical Device Directives
- Use ISO 13485:2016 as the basis of regulatory requirements worldwide.
How will I benefit?
- Take the first steps towards ISO 13485:2016 certification
- Understand how you can better meet customer and regulatory requirements leading to increased patient safety
- Find ways to increase efficiency and cost savings through quality management
- Monitor supply chains to achieve continuous improvement
- Develop safe and effective medical devices
- Motivate employees through CPD.
- Training course notes
- Loan copy of the standard (to be returned after the course)
- Suitable for small groups
- Suitable for single person
- Learn from other organizations