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Medical Device Software Regulatory Consulting

Get a Handle on Medical Device Software Requirements with the IEC 62304 Action List Below

IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. The standard was developed from the perspective that product testing alone is insufficient to ensure patient safety when software is involved. The standard requires all aspects of the software development lifecycle to be scrutinized.

With this easy-to-follow high-level check list, you’ll learn the key elements necessary to get started on your submission, including:

  • Processes & controls
  • Performance & safety testing
  • Specific inclusions for risk management
  • AND MORE!

Still feeling overwhelmed? Give us a call, and we’ll connect you with one of our regulatory affairs experts.

Please note: This Action List is not intended as advice for compliance with this or any other regulatory requirement. You should consult with your regulatory affairs professional to determine the appropriate compliance strategy for your particular medical device.

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