Risk Management and Design Controls for Medical Devices and IVDs
This instructor-led, three-day course covers design control principles relative to U.S. 21 CFR Part 820, ISO 13485:2016, the EU MDR/IVDR, and key elements of ISO 14971:2019. It provides a clear overview of essential medical device design control requirements and addresses common misunderstandings of regulatory expectations. Practical guidance is offered across all phases of design and development, including methods for performing retrospective gap analyses of design history files to support compliant EU MDR/IVDR technical documentation. The curriculum emphasizes ISO 14971:2019 obligations for establishing, documenting, and maintaining a risk management process throughout the device lifecycle. An optional two‑hour ISO 14971:2019 eLearning module is included for completion prior to the live course. The program is highly interactive, with practical instruction, case studies, and a competency assessment.
Tutor
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Learning Outcomes
At the end of this training, learners will be able to:
- Identify key regulatory requirements for design controls and risk management
- European Union Regulations
- Quality System Regulation
- ISO 13485:2016
- Identify key principles of ISO 14971:2019
- 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
- Identify how risk management affects quality management system practices
- Recognize one method for the practical application of risk management principles
Who Should Attend
This class is vital for both regulatory affairs and quality assurance professionals involved in developing and manufacturing medical devices. This course provides critical knowledge for those looking to expand their knowledge of comprehensive design and risk management processes and their interactions with the entire lifecycle of a medical device from conception to decommissioning and disposal.
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