Design Controls for Medical Devices and IVDs
This instructor-led course covers design control principles and design and development regulatory requirements relative to U.S. 21 CFR Part 820, ISO 13485:2016 and the EU MDR. Practical examples will be incorporated.
This course covers important requirements for medical device and IVD design controls. Learners will benefit from open dialogue and the sharing of current design and development processes; highlighting how misperceptions of regulatory requirements have led to less-than-optimal practices. This course also provides guidance for 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.
Learning Outcomes
At the end of this training, learners will be able to:
- Identify key regulatory requirements for risk management
- European Union
- Quality System Regulation
- ISO 13485:2016
- Identify key principles of ISO 14971:2019
- Identify key regulatory requirements for design controls:
- European Union
- Quality System Regulation
- ISO 13485:2016
- Recognize potential exemptions from design control requirements
- Identify when, during a design and development project, design control requirements apply
- Conceptualize graphically a design control process
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. This course provides critical knowledge for both regulatory affairs and quality assurance professionals.
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