Risk Management for Medical Devices: ISO 14971:2007

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Tue, Apr 08, 2014
60 Minutes
Product Description

Insights On Medical Device Risk Management In Accordance With ISO 14971

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:

  • Laws and Regulations
  • Overview of ISO 14971
  • ISO 14971 and EN ISO 14971: 2012
  • Risk Management Process
  • Key Elements of Risk Management
  • ISO 14971 and US FDA
  • Relationship with Quality Management Systems
  • Clinical Evaluation
  • Common Mistakes in Risk Management
  • How to Reduce and Prevent Common Mistakes
  • Risk Management and Product Liability Cases
  • FDA Enforcement Cases
  • Speaker’s PASS-IT Suggestions/Recommendations
  • Conclusion

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:

  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Anyone Interested in the US FDA’s Strategic Priorities

Clear your doubts in the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

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.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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