A Practical Approach to Medical Device Risk Management

is being presented by Harvey Rudolph, Ph.D., HRRM, LLC, Risk Management Consultant and airs on Tuesday, August 3rd, 2010. For more details or to register please visit our site at www.fxconferences.com

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.