The risk management standard (ISO 14971) is applicable to medical devices including in vitro diagnostic medical devices (IVDs). ISO 14971 provides a process for a device firm to identify the hazards and hazardous situations associated with medical devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control.
Join Dr. David Lim, Ph.D., RAC, ASQ-CQA in this 60 minute audio session, where he will help you understand and apply key elements of risk management for medical devices so that risk management can be implemented in an adequate, sufficient manner. David will discuss practical aspects of medical device risk management in accordance with ISO 14971. In addition, this session will assist you in understanding and implementing practical aspects of risk management in a way to greatly improve your quality management systems.
In this presentation, David will share his practical, actionable, sustainable solutions/strategies in an integrated, thorough (“PASS-IT”) manner.
Areas To Be Covered in this Session:
The speaker will answer your questions in a Q&A session to help you with the doubts and queries you may have.
Who should attend:
Clear your doubts in the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
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.