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Medical Device Software Validation and Verification (V&V) Consulting for FDA and IEC 62304

Oriel STAT A MATRIX can assist you in meeting the IEC 62304, US FDA and international software validation requirements. 



IEC 62304 is the international standard that specifies software lifecycle development requirements for medical devices. Compliance with the standard is mandatory in Europe and it is recognized as a consensus standard by the US FDA. Among other things, it requires medical device manufacturers to group their software into one of three safety classifications.

  • CLASS A – No injury or damage to health possible (if failure occurs)
  • CLASS B – Non-serious injury is possible (if failure occurs)
  • CLASS C – Death or serious injury is possible (if failure occurs)

Selecting the appropriate class for your device is not always clear cut, but it has tremendous (especially between Classes A and B) implications for code development and how you approach IEC 62304 compliance. Our medical device software validation consultants can assist you in selecting a classification and comply with V&V aspects of the standard, including its corresponding impact on your risk management files and design control documentation. Building your validation files early in the development process makes the process of obtaining regulatory clearance easier and reduces regulatory risk.

Our validation consulting team understands FDA software guidance and related regulatory requirements

It is difficult to know how much testing is appropriate to assess the safety and effectiveness of software, and the FDA guidance document on software won’t answer that question for you. The goal is to test to the point where you have an appropriate level of confidence that the software will meet requirements for safety and usability. We can assist you in making this determination.

Because we are 100% focused on medical device regulatory compliance, we fully understand how the FDA software guidance documents and IEC 62304 integrate with one another. That’s important because those requirements affect the contents of your FDA 510(k) submission and/or European technical documentation in support of CE Marking. Tracking all testing done in support of your regulatory submissions is vital.

Contact us today to learn how we can help you comply IEC 62304, US FDA and international software validation requirements. 

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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