Course description
Design Controls for Medical Devices
This course provides an understanding of design control principles and the design and development regulatory requirements relative to U.S. 21 CFR Part 820, ISO 13485:2016 and EU MDR, as well as practical examples to maximize efficient executions and documentation practices.
Learn important requirements for medical devices and IVDs design controls, and benefit from open dialogue and sharing of current design and development processes highlighting how misperceptions of regulatory requirements have led to less-than-optimal practices. This course provides knowledge to assist in all phases of medical device design and development projects, as well as retrospective gap analysis of design history files, to help develop new technical files under the EU MDR and IVDR.
This instructor-led course is highly interactive and provides you with an understanding of the risk management definitions and principles of ISO 14971, and specifically addresses the regulatory expectations for medical device design control requirements.
Upcoming start dates
Suitability - Who should attend?
This class is vital for any medical device research and development professional, regulatory scientist and/or clinician involved in developing and manufacturing medical devices.
Outcome / Qualification etc.
At the end of the course, you will:
- Recognize risk management definitions and principles of ISO 14971;
- Identify how risk management affects quality management system practices; and
- Recognize regulatory expectations relative to Design Control requirements.
Training Course Content
Objectives:
- Properly identify design control requirements
- Describe the design review, design verification, and design validation processes
- Understand the links between design and risk management
- Understand thedesign transfer process
- Understand postmarket surveillance
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Reviews
Average rating 4.5
I was extremely impressed with the course participation and engagement by the group. This speaks highly to the instructor’s abilities to make it relevant to all participants. Bo...
Really liked the breakout rooms - helped to make it very interactive during these hard times.