Risk-based is the new way to view all activities. When it comes to patient safety, however, risk and its reduction are the key driving factors.
From its beginnings in implementation of the international standard for risk management (ISO 14971:2007), risk management has spread its tentacles into many other international standards as well as FDA regulation.
The Medical Device Directive (MDD) in the EU includes requirements that don’t line-up with the international standard. Subsequently, the EU harmonized EN ISO 14971:2012. With the publication of the Medical Device Regulation (MDR), the requirements change. As a result, the EU will publish and harmonize a new version.
Another major change comes with ISO 13485:2016 and its stronger emphasis on risk management activities. This new QMS standard, coupled with the Medical Device Single Audit Program (MDSAP) will also rile the regulatory seas.
Many devicemakers have simply thrown up their hands. That doesn’t work ... and they have the warning letters to prove it.
What’s lacking is guidance from experts who can help untangle risk management’s mysteries and set you on a path to full compliance.
FDAnews has teamed up with Ombu Enterprises to help you batten down the hatches, by offering two-day workshops that dive deep into every aspect of risk management compliance.
With dates in spring and fall for your convenience, these workshops are the answer to your risk management woes. You’ll cover:
- Fundamental concepts of risk management
- Regulatory structures of the U.S., Canada, and the EU current state and the future state
- Warning Letters analysis — avoiding pitfalls that bring others down
- The process flow in the international standard ISO 14971:2007
- The relationship between an ISO 14971:2007 Risk Management System (RMS) and an ISO 13485:2016 Quality Management System (QMS)
- The EU variant, EN ISO 14971:2012 and how to implement it
- Role of production and post-production information including linkage to the EU’s Requirements for Clinical Evaluation
- And much more!
Plus three new sessions have been added for 2017:
- The EU Regulations including the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR)
- The Draft Guidance Documents for 510(k) Changes and risk management considerations
- Cybersecurity focusing on the FDA-CDRH Premarket Cybersecurity and Postmarket Cybersecurity guidances
Your risk management Sherpa is Dan O’Leary, a favorite presenter at dozens of FDAnews-sponsored workshops, provides the understanding and practical tools to join the disparate pieces into a coherent whole and create a solid foundation for the coming changes. Mr. O’Leary boasts 30+ years’ experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs. His consultancy, Ombu Enterprises LLC, focuses on operational excellence and regulatory compliance particularly for small manufacturing companies. He is an ASQ-Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Select dates in June or September, whichever best fits your schedule. It could be the best investment of two days’ time you make this year.