ISO 14971 Regulations

Achieve ISO 14971 Certification

ISO 14971 specifies a process for medical device manufacturers to identify the hazards, or risks, that are associated with their products and to create the necessary controls to monitor them. Understanding this regulation is also critical to establishing the safety of your product per IEC 60601-1 3rd Edition Amendment 1 requirements.

At MethodSense, our medical device consultants will help prepare your business operations and documentation to establish your compliance with ISO standards and enable you to demonstrate your commitment to product safety, quality and reliability.

ISO 14971 Certification Solutions

ISO 14971 establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. These activities are also required by higher level regulation and other quality standards, such as ISO 13485. Our medical device consultants work with you to:

  • Assess the essential performance of your medical device
  • Identify potential hazards
  • Estimate the severity and likelihood of the hazards
  • Create controls to minimize the risks

Using LuminLogic Smart Enterprise Solutions, our regulatory document management tool, your materials will be organized in a way that makes it easy to demonstrate the safety and effectiveness of your device and risk management processes. Click here to learn more about our regulatory document management software.

Our goal is to help you achieve easier compliance, more efficient validation and improved process management.

To Ensure Your Device Gets To Market Quickly And Without Unnecessary Delay, Schedule An Appointment With One Of Our Regulatory Affairs Consultants Today

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