The risk management for medical devices is described by the International Organization for Standardization (ISO). Those who are interested in risk management should understand the requirements of ISO 14971:2007, which are applicable to the life-cycle of a medical device.
Join Dr. David Lim, Ph.D., RAC, ASQ-CQA in this 60 minute audio session to discuss the impact of ISO 14971 on the risk management and risk-based decision making processes including its application to ISO 13485. He will provide an overview of risk management for medical devices including in vitro diagnostic devices (IVDs) in a systematic, integrated manner.
David will help you comprehend the risk management tools, methods and processes applicable to the device firms. In addition, he’ll provide great opportunities for the attendees to develop and implement a risk management strategy in a systematic, integrated manner.
In this 60-min presentation, David will guide you through the details of how to implement a systematic, integrated risk management for medical devices including IVDs in a CAC-SI manner, potentially helping you save millions of dollars including an enormous amount of time, effort and resources.
Areas Covered in the Session
Clear your doubts at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Who Will Benefit:
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.