Download Your IEC 62304 Action List

Download Your IEC 62304 Action List

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 life cycle to be scrutinized.

With this easy-to-follow high-level IEC 62304 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

Please note: This IEC 62304 Action List download 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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