This Risk Management training will discuss how to develop a compliant risk management process as a part of medical device Quality System built as per ISO 14971 standards.
Why should you Attend:
As the European Union Medical Device Directive changes are moving forward, more Notified Bodies are upgrading their approach to medical device risk management. The FDA is now citing manufacturers for risk management issues and these are starting to appear in Warning Letters. With the renewed emphasis on Enforcement by FDA, and more scrutiny in the premarket application arena, manufacturers need to upgrade their approach to Risk Management to fully comply with the ISO 14971 Risk Management standard. ISO 14971 is the FDA recognized standard and is also the Harmonized Standard in the EU scheme for medical devices.
Companies are continuing to upgrade their Quality Systems to include new concepts of Risk Management. This presentation has been updated to include some example forms and flow charts for an integrated risk management and quality system. This presentation will provide guidance on developing a fully compliant Risk Management process as part of the medical device Quality System. Manufacturers can use this presentation to guide their improvements in developing a compliant risk management process fully integrated into the quality system.
Areas Covered in the seminar:
- How to use the Risk Traceability Summary to document Risk Management activities during design, production and post-production.
- Examining Risk Management requirements for each phase of the product lifecycle.
- Identifying documentation requirements for Risk Management.
- Developing forms and reports that provide objective evidence of risk management compliance.
- Integrating Postmarket Risk Management activities with CAPA.
- How FDA's Health Hazard Evaluation relates to Risk Management.
- How Risk Management Tools relate to documentation of Risk Management activities.
Who will benefit:
- Regulatory Affairs personnel
- Regulatory Affairs Managers
- Qualtiy Managers
- Quality Assurance Engineers
- Design Managers
- Process Engineering
- Risk Managers
Instructor Profile:
Edwin L. Bills, is the Principal Consultant for Bilanx Consulting LLC, a consulting firm that provides assistance to medical device companies in compliance with US FDA regulations, in development of Quality Management Systems and Risk Management processes. Edwin has over 20 years experience in the medical device industry and has participated in development of industry standards, including ISO 14971. In his consulting role he has assisted companies in Warning Letter responses. Edwin has also participated in training both company and FDA personnel in the Quality System Regulation and Product Risk Management.
