The gale force flags are flying!
Risk management is just plain hard — complicated, conflicted, confusing. And it’s getting even harder.
The international standard is under revision. While the changes in the process are not intended as “major”, the new standard adds new definitions… changes the clause numbering… introduces new requirements… changes many of the annexes, and moves them to a new document.
In a sister storm, the EU is in transition to new regulations. There are new concepts… new risk reduction requirements… and new applications. Two areas of impact are side-effects (residual risk) and benefit-risk analysis as a life-cycle requirement.
The storm surge affects the many standards that require ISO 14971:2007. Some of them are already in various stages of transition, but all will need an update. Your procedures in these areas require a major refit.
- ISO 10993-1:2018 on biocompatibility is the new version — it currently requires ISO 14971:2007 but will need an adjustment.
- IEC 62366-1:2015 on usability has an amendment underway that may include some issues related to the new risk management standard.
- Other areas that will require adjustment — at the SOP level initially — include software, electrical medical devices, and animal tissues.
Your risk management procedures will require a major overhaul.
This workshop — led by industry expert Dan O’Leary — provides the information you need to batten down the hatches and survive the storms. Dan will explain the new version of 14971 and its implementation. He’ll cover the new EU regulation’s risk management requirements through the product life cycle (initial CE Mark and post-market issues). And provide current information on the standards that require risk management and their implementation.
During the workshop you’ll:
- 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 new standard, ISO 14971:xxxx
- Understand the details of the EU variant, EN ISO 14971:xxxx including the five Z annexes
- Understand the risk management changes arising from the EU-MDR and EU-IVDR
- Review the potential relationship between the ISO 14971:xxxx 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
Your risk management guide is Dan O’Leary, a favorite presenter at dozens of FDAnews-sponsored workshops. Dan provides the understanding and practical tools to join the disparate pieces into a coherent whole and create a solid foundation for the coming changes. Dan boasts more than 30 years’ experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs.
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.