Risk management is required by almost all regulatory bodies and is necessary for implementing many standards that medical device manufacturers use in designing and developing their products. Over the past ten years, most manufacturers have tried to model their risk management system on the one described in ISO 14971, because that is the one accepted by most regulatory bodies and referenced in most standards. However, myriad problems have been encountered in trying to implement risk management within existing quality management systems. Why is this? If ISO 14971 is so great, why isn’t it easier to do? What are the factors inhibiting success in making risk management work? In this audio conference, leading risk management expert Dr. Harvey Rudolph discusses some of the major issues facing medical device companies, and practical solutions.

This audio conference covers:

• Embracing a risk management philosophy
• Making your risk management system and quality system work together
• Using risk analysis tools properly
• Making the results of risk analysis work for you
• Making sure it all hangs together

About the speaker:

Dr. Harvey Rudolph has worked as an independent consultant in risk management for the past three years. Prior to that, he worked for UL for seven years as Global Program Manager and FDA for 25 years, retiring as Deputy Director of the CDRH labs. He is a major author of ISO 14971 and co-chairs the US Technical Advisory Group for the ISO/IEC Joint Working Group on Risk Management

Who should attend?

• Department Managers
• Project Leaders
• Quality
• Regulatory
• Research & Development