Understanding IEC 62304 Compliance

Understanding IEC 62304 Compliance

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. However, it can be a difficult standard to understand.

In this paper you will learn about:

  • Whether or not your device must comply with the standard
  • The roles of Basic Safety and Essential Performance
  • Common scenarios manufacturers miss
  • How IEC 62304 compliance is assessed
  • Key pitfalls to be on the look out for

Because it has been harmonized with the Medical Device Directive in the EU and Recognized as a Consensus Standard by the FDA in the US, IEC 62304 can be used as a benchmark to comply with regulatory requirements in both markets. To date, this standard has been recognized in most countries that use compliance standards to fulfill regulatory requirements. So, if you’re looking to be competitive in a global marketplace… this article is a must read!

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