ISO 14971: Application of Risk Management for Medical Devices

Interactive ISO 14971 Risk Management Consulting Solutions for Medical Devices

Risk Management is a major requirement of the third edition of IEC 60601-1. Our consultants work hand-in-hand with you and your team to develop strategic solutions that will address your specific needs. We provide support throughout your entire product development cycle to help you navigate the complexities of building a Risk Management File to incorporate risk analysis, hazard analysis, production/post-production device monitoring, and more.

At Intertek, we know medical devices, we know risk management, and we know how to help you identify the simplest, most effective approach to constructing your Risk Management File. Ask us about our “3-Step Kick-Off" for ISO 14971 Risk Management Consulting:

  1. In-depth review of your regulatory strategy and determine how this project aligns with your business objectives
  2. Evaluation of your current compliance to three major components of IEC 60601-1:
    • Risk Management Process (ISO 14971)
    • Risk Management File (ISO 14971)
    • Product Risk Analysis (IEC 60601)
  3. Development of a project plan that ensures you receive the support you need to fill any compliance gaps

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Intertek does not provide consulting services for management systems certification. Any consulting activities provided by Intertek are separate and independent from certification activities.


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