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Please share your method used for PEMS Validation

Hi, everyone

Could you please share your method used for PEMS validation? The validation is defined to determine whether the requirements for intended use are satisfied and ensure that the right product is built. The definition is clear, but what does that mean on a practical level?



Staff member
Super Moderator
PEMS = Programmable Electrical Medical Systems (and the companion PESS = Programmable Electrical Subsystems).

So we're effectively talking about software validation. Validation of software goes beyond testing, you need to have the controls in place to demonstrate the software is built and maintained properly. Part of validation is demonstration (test) that the requirements are met. Beyond meeting requirements, though, will the software hold up to actual use?

I would suggest validation (these days) include:
  • requirements verification (does it fulfill the requirements - and includes demonstration that software-implemented risk controls are effective)
  • risk-based exploratory testing (if a user can do something they will... and how will the system react)
  • cybersecurity analysis (which could include penetration testing, etc.)
  • human factors assessment (does the software promote safe and effective use)
  • low-level static analysis
  • SOUP analysis
  • configuration status accounting audit
  • internal audit for compliance to a sound software development lifecycle* including post-market support (62304 is a good standard)
(*Everyone expects that the software lifecycle be defined, be 'state of the art,' and followed.)

That's just off the top of my head... and I'm only half-way into my coffee so there may be more.


Staff member
Super Moderator
That's correct. But it is a harmonized standard (EU) / recognized consensus standard (US) (and referenced by 60601-1). A look at the FDA guidance on software validation may help.


Involved In Discussions
The informative annex C of 62304 shows the relationship to several other standards. The V-model shown in C.4.2 is somewhat 'busy' but should provide some of the insight you seek.
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