Risk Management for Medical Devices and IVDs: Systematic, Integrated Approaches

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 Minutes
Product Description

Know The Impact Of ISO 14971 On The Risk Management And Risk-Based Decision Making Processes

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

  • Applicable statute(s), regulations, and definitions
  • Risk management policy/ plan
  • Risk identification, analysis and evaluation
  • Risk analysis (severity, probability and detectability)
  • Risk control measures and mitigation
  • Risk management tools and methods
  • ISO 14971:2007 and EN ISO 14971:2012
  • ISO 13485:2003 and EN ISO 13485:2012
  • Risk analysis and design control
  • Risk analysis tools
  • Risk analysis versus usability
  • How to integrate risk management into the device design and development
  • Doing risk management right without wasting resources
  • Practical aspects (value) of risk management
  • Risk analysis versus CE marking (MDD, IVDD, and AIMDD)
  • Risk management for IVDs
  • Risk analysis versus IEC 60601-1
  • Relationship between risk management, complaint handling, MDR and CAPA
  • Speaker’s PASS-IT tips

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:

  • R&D
  • Regulatory Affairs
  • Quality
  • Regulatory Compliane
  • Clinical Affairs
  • Consultants
  • Legal and Compliance Officers
  • Marketing Professionals
  • Senior Management
  • Anyone Interested in the Subject

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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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