What You Will Learn
At the conclusion of this workshop, you will be able to:
-
Identify integration of risk into the European Union (EU) Medical Device Regulation (MDR), the Medical Device Single Audit Program (MDSAP), and the US FDA quality system regulation (QSR).
-
Describe the purpose, structure, and key concepts of ISO 14971 and ISO/TR 24971, including the definitions for benefit, state of the art, and reasonably foreseeable misuse and the expanded requirements for production and post-production activities.
-
Understand the relationship of ISO 14971 to EN ISO 14971:2019, ISO 13485, IEC 60601, IEC 62304, IEC 62366, and ISO 10993.
-
Articulate the requirements for each step of the risk management process, including risk management planning, risk analysis, risk evaluation, risk control, benefit-risk and residual risk analysis, risk management review and reporting, and production and post-production activities.
-
Through workshops, create a risk management plan, apply tools for risk assessment and risk control, conduct a benefit-risk analysis, create a risk management report, and assess production and post-production information for possible action.
-
Understand production and post-production risk management requirements, including CAPA activities and postmarket surveillance processes.
-
Describe how to use the process and risk-based approach of ISO 13485 to ensure the continued suitability, adequacy, and effectiveness of your risk management process
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.
Virtual Half-Days:
5
In-Person Full-Days:
3
CEUs:
2.5