An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971 Webinar
Time: 10:00 AM PDT, 01:00 PM EDT
Duration: 75 Minutes
This webinar will cover all major elements of ISO 14971 and present a methodology for integrating the requirements of this standard into the product development process to ensure that the requirements of the standard are met, and the medical device is designed to be safe and effective. The webinar will specify how risk management activities are incorporated in all phases of development and other related processes (CAPA, Complaint Management, Non-Conformances), and what supporting documentation needs to be gathered in order to ensure that decisions made based on what is learned as part of the risk management process are adequately justified and documented.
Why Should you Attend:
ISO 14971 Medical devices - Application of risk management to medical devices is a voluntary standard that medical device manufacturers should incorporate into their design and development process in order to ensure medical devices designed are safe and effective. The FDA now also recognizes ISO14971, and can audit to it if manufacturer´s claim they conform to it. Although ISO 14971 has been in place since 1998, many companies still find it difficult to properly interpret the requirements of the standards and having a risk management process which is not helpful in designing robust, safe medical devices.
Objectives of the Presentation:
- How are risk management activities integrated throughout the development process
- The roles that Hazard Analysis, FTA, FMEA, HAZOP and PFMEA play in an Integrated Risk Management Process
- How to control and verify risk mitigations
- How to perform a Risk Benefit Analysis
- The importance of maintaining Risk Management documents in the Post Production era
- What information to include in the Risk Management Plan and Report for better auditability
- How to integrate Risk Management with CAPA, Complaints and Non-Conformance processes