Risk management according to ISO 14971:2019 / EN ISO 14971. 09396 -
Seminar / Kurs
von TÜV Rheinland Akademie GmbH
How medical device manufacturers realize, apply and document risk management according to ISO 14971 / EN ISO 14971.
All medical device manufacturers must implement and document a risk management process. Learn how to implement the requirements of ISO 14971:2019 / EN ISO 14971 over all life cycles for your medical device and take into account the changes of the third edition from 2019. You will learn how to perform a risk analysis, correctly assess the risks and successfully minimize them. Regulatory requirements to minimize the risks associated with medical devicesRequirements of European regulations (MDR, IvDR)Risk management EN ISO 14971 vs. quality management EN ISO 13485 - Risk-based approach to products and QMS processesISO 14971:2007 vs. ISO 14971:2019new and amended terms and definitionsStructure and set-upRisks, hazards and their evaluationProcedure and methods for risk analysis (e.g. fault tree analysis, FMEA)Risk management versus risk analysisHolistic risk assessment over the entire life cycle and connection with post market surveillanceDocumentation in risk management
You will get an overview of the current regulatory requirements for risk minimization that manufacturers of medical devices must comply with.You will learn about the contents and requirements of ISO 14971:2019 / EN ISO 14971 as well as the purpose and procedure of a risk analysis.You will be enabled to systematically implement the risk management process in your company.You will deepen your knowledge with practical examples.
The seminar is for regulatory affairs specialists, quality management specialists as well as employees from the areas of quality and product management, design and development from companies in the medical device industry.
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