Introduction to ISO 13485 Medical Device Quality Management System
ISO 13485 shapes the quality management systems for medical device manufacturers globally. This international standard shows customers and competitors that you take quality seriously in your medical devices design, research, development and manufacturing. Sign up for our Introduction to ISO 13485 Medical Devices Training Course and be ahead of your competition.
ISO 13485 applies to design, development, production, installation and servicing of medical devices. And compliance is a measure of your ability to meet customer and legal requirements.
Who should attend?
- Senior management and those tasked with implementing ISO 13485
- Quality managers and regulatory affairs managers
- Internal and external auditors
This training course is HRDF approved under the SBL scheme.
What will I learn?
- Understand the importance of ISO 13485 on an international scale
- Differentiate between ISO 13485 and ISO 9001
- Get to grips with the different elements of ISO 13485 and ISO 14969:2005
- Understand the relationship between ISO 13485 and ISO 14971
- Define ISO 13485 management roles and responsibilities
How will I benefit?
- Take the first steps towards ISO 13485 accreditation
- Understand how you can better meet customer and regulatory requirements
- Find ways to increase efficiency and cost savings through quality management
- Monitor supply chains to achieve continuous improvement
- Develop safe and effective medical devices
What does the fee cover?
- Training course notes
- Loan copy of the standard (to be returned after the course)