What You Will Learn
At the conclusion of this workshop, you will be able to:
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Understand global regulatory compliance requirements, including those specific to the EU MDR, MDSAP, and US FDA.
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Describe the purpose, structure, clauses, and key concepts of ISO 14971:2007 and related standards, and understand content deviations with EN ISO 14971:2012.
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Articulate the requirements for each step of the risk management process, including risk management plan, risk analysis, risk evaluation, risk control, risk benefit, risk management file, and post-production analyses.
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Create a risk management plan, apply tools for risk assessment and risk control, conduct a risk-benefit analysis, and create a risk management report.
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Identify software risk management expectations in IEC 62304 and the application of ISO 14971 to software (ISO/TR 80002-1).
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Understand post-production risk management requirements, including reactive CAPA activities and proactive postmarket surveillance.
Who Should Attend
Recommended for design managers and engineers; manufacturing, service, quality assurance, reliability, research and development, and regulatory affairs professionals; and other cross-functional team members in a medical device environment. All attendees must have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485.
Number of Days:
3
CEUs:
2.5