Post Approval Risk Management Strategy
Duration: 60 Minutes
We will discuss how Risk Management Files are developed and maintained in accordance with ISO 14971 throughout the product lifecycle.
Organizations wishing to market Medical Devices in Europe must develop Quality Management Systems in accordance with ISO 13485 and ISO 14971. ISO 13485 requires proof of Risk Management use and FDA expects it. We no longer refer it as Risk Assessment because that is only a small part of what is required. Risk Management activities start at concept design with the development of the Risk Management File. This file provides information on the original risk analysis, risk evaluation, and control measures established at the time of design release to manufacturing. Any product changes, including labeling, must be evaluated in accordance with your Risk Management procedures.
Why Should you Attend:
Manufacturers and Study Sponsors must understand the aspects of Risk Management, and how to effectively document their efforts. The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers or sponsors to ensure that the benefits of a product outweigh its risks. FDA may require risk evaluation and mitigation strategies (REMS) prior to or post approval. Regardless of whether FDA has made the request it always best to be proactive and have your risk management activities well documented.
Objectives of the Presentation:
Who can Benefit:
- Overview of ISO 14971 Medical devices - Application of risk management to medical devices
- Discussion of key requirements
- What written procedures and training are required
- How to develop Risk Management Files
- How to apply Risk Management to Post-Approval Labeling Risk Management Strategy
- Understanding of what auditors expect
- Quality Assurance Managers/Personnel
- Regulatory Managers/Personnel
- Manufacturing managers, supervisors & personnel
- Engineering managers, supervisors & personnel
- Marketing managers, supervisors & personnel
- Internal Auditors
- Senior management executives (CEO, COO, CFO, etc.)
- Project Managers