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IEC 60601-1 and Medical Device Risk Management

The IEC 60601-1 standard is intended to serve as a benchmark for the development of safe and effective electro-medical devices. It focuses on the basic safety and performance of your medical device’s electrical system. With the transition to IEC 60601-1 3rd Edition, there’s now a greater emphasis on risk management documentation and performance. You also have more choices in determining how safety and Essential Operational Performance are maintained within your Risk Management Program.

While there are many advantages to the changes found in IEC 60601-1 3rd Edition, failure to implement them can cause costly delays in getting your device to market.

At MethodSense, our goal is to guide you through the implementation of an effective medical device risk management process, providing expert combination products consulting guidance and interpretation of the standard, so you can achieve IEC 60601-1 3rd Edition compliance. Our combination products consulting experts can guide you – and your engineers – starting as early as the initial design process.

Together we will:

  • Review the standard you must comply with
  • Conduct a gap analysis of your Risk Management Program against ISO 14971
  • Update your Risk Management Documentation
  • Complete the IEC 60601-1 3rd Edition tables
  • Leverage our engineering experience
  • Submit your documentation to your test house

Meeting your safety standard requirements ensures:

  • Conformity to globally-approved standards
  • Reduced risk of liability because of your documented safety standards
  • Increased opportunities in the global market

For assistance developing your medical device Risk Management Program or completing IEC 60601-1 3rd Edition documentation, contact one of our Risk Management Specialists today.

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