Enabling you to identify and mitigate the intrinsic risk in your operations, supply chains and business processes.
Evaluating how your products and services meet and exceed quality, safety, sustainability and performance standards.
Validating the specifications, value and safety of your raw materials, products and assets.
The 3rd Edition of IEC 60601-1 represents a shift in philosophy from the 2nd Edition, including a greater emphasis on risk management and essential performance. As with any other standard change, a failure to implement these new requirements in a timely manner could cause costly delays in getting your device to market.
This white paper reviews the “new philosophy” of the 3rd Edition, and outlines the specific changes from the 2nd Edition. We also provide you with an update on the acceptance of the 3rd Edition in the world’s largest markets for medical devices.
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