Effective medical device risk management follows a well-defined process.
The process in ISO 14971:2007 and EN ISO 14971:2012 is simple and straightforward. While the process has clearly defined steps in a natural flow, many companies don’t follow it, and, as a result, create numerous problems. In the worst case, the incorrect process results in inadequate protection, patient or user harm, adverse event reports, and lawsuits.
Medical device risk and its management are not abstract concepts. ISO 14971:2007 — the international process standard — provides a method to protect patient and user safety. The standard supports specialized risk management topics including usability, biocompatibility, cybersecurity, and electrical safety.
The Medical Device Directive, MDD, has requirements that differ from the international standard. The process remains the same, but some of the process steps change. EN ISO 14971:2012, a harmonized standard, enumerates the differences.
The Medical Device Regulation, EU-MDR, has additional requirements, likely to trigger a new European version of the standard.
This workshop, led by industry expert Dan O’Leary, provides the information you need to understand and implement an effective medical device risk management process. The first day focuses on the risk management process, providing both an overview and the details. It explains the differences among the international version, the EU-MDD version, and the anticipated EU-MDR version. The second day focuses on applications that require an effective risk management process.
During the workshop, participants:
- Learn the fundamental concepts of risk management
- Understand the regulatory structure including the US, Canada, the EU current state, and the EU future state
- Review recent FDA Warning Letters and understand how to avoid their problems
- Learn the process flow in the international standard, ISO 14971:2007
- Understand the details of the EU-MDD variant, EN ISO 14971:2012, and its implementation
- Anticipate risk management changes from the EU-MDR and EU-IVDR
- Review the relationship between an ISO 14971:2007 Risk Management System (RMS) and an ISO 13485:2016 Quality Management System (QMS)
- Review the risk management audit tasks from the MDSAP Audit Model
- Understand the role of risk management in post-market surveillance
Risk management affects nearly every aspect of medical device manufacture. Yet many devicemakers lag behind the curve, courting warning letters or worse. Get your operation up to speed quickly and easily.