What You Will Learn
At the conclusion of this workshop, you will be able to:
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Identify design control requirements related to FDA, EU MDR, MDSAP, and ISO 13485.
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Describe the design review, design verification, and design validation processes.
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Evaluate the links between design, usability, and risk management.
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Understand the pros and cons of the linear and iterative processes and the approach to systems design.
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Identify strategies for risk-based sampling and statistical justification.
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Describe best practices for the design transfer process.
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Practice the design control process in workshops, building a design history file (DHF).
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Describe postmarket surveillance and input to design changes.
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Identify FDA requirements and MDSAP outcomes and linkages related to the design and development process in preparing for audits.
Who Should Attend
Anyone managing, developing, or engaging in the design of medical devices, including direct engineering functions, QA/QC, production management, and regulatory, as well as anyone else who has a role in building a robust regulatory-compliant environment. Attendees must have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485.
Number of Days:
3
CEUs:
2.5