• The connections of medical device quality systems to the elements and workings of risk management from risk analysis through post-production
• The interactions of risk management elements within the medical device quality system including management responsibility, resource management, product realization, measurement analysis and corrective action
• The stand-alone requirements of risk management in a set of activities managed within a medical device quality system.

• Individuals responsible for and who interact with a medical device quality management system
• Quality and regulatory professionals including: Managers, Directors, Audit team members
• Upon entering the course it is recommended that the webinar attendee is familiar with the ISO 13485:2003 Medical Device Quality Management System

COURSE OUTLINE

Presentation Goals:

1. The webinar attendee with be presented with a review of process-based medical device quality system 13485:2003
2. The webinar attendee will be presented with elements of ISO 14971 Medical Devices – Application of risk management in medical devices as follows:
   i. Risk Management Planning
   ii. Risk Evaluation
   iii. Risk Control
   iv. Residual risk evaluation
   v. Risk Analysis
   vi. Risk Control and Reduction in Post-Production
3. The webinar attendee will be provided with an overview and discussion of the concept of risk components:
   i. probability of the occurrence of harm and how often the harm may occur and;
   ii. consequences of such harm and how severe said harm may be
4. The webinar attendee will understand medical device stakeholder interest in medical device risk including: practitioner, health care organizations, governments, industry, patients and the public
5. The webinar attendee will be presented with the integral application of ISO 14971 in a quality management system
6. The webinar attendee will be presented with the interactions of risk management and risk assessment within ISO 14971