Why FDA Compliance (knowledge) Matters

Is your software engineering vendor helping or hurting you?

When you are reviewing the myriad software engineering vendors out there, as part of your due diligence – for your own sanity, make sure you can verify their solid understanding of FDA and International compliance across the board.

Why do I mention this?

Recently, a team building Version 2 of an on-market medical device, asked us to review their software engineering vendor’s QMS documentation – prior to transitioning from prototype to ‘actual product’ design and development – because they had a funny feeling the documentation wasn’t 100% complete.

During our initial Q&A phase, our process expert started requesting core documentation for the Class III device, which would be needed for their upcoming submittal. At the end of this first meeting – we walked away with more questions than answers and it was immediately clear the client’s vendor didn’t have everything in place, at this phase.

Here’s how it played out.

We conducted a gap analysis of their entire QMS process including all documentation for the new product – especially all artifacts that could be provided by the vendor.

Post gap analysis showed the following items were missing, or incomplete:

  • SOP
  • WI
  • SDP
  • Requirements
  • Specifications
  • Risk Management File
  • Protocols

After we reviewed the gap analysis findings with our client, they decided – in order to meet a very important deadline – that they would scrap all the work that was performed by this new software development vendor, and go back to the vendor they used to design/build/manufacture their first product.  That first experience was 100% successful, with complete FDA acceptance.

The original vendor was more expensive, which was why they opted for a more cost-effective local vendor for the 2nd product version.

Instead, they had to throw away all the work the newer vendor performed – including 9 months of lost time – because they’d trusted the new vendor’s website compliance claims, and all their compliance experience promises.

Knowing the right questions can save you a lot of time and money.

Because we at Advantu pride ourselves on our regulatory and quality management system expertise – we sometimes take for granted that potential clients may not always know the right questions to ask.

Here are our recommended questions.

Whether you are planning a class I, II or III medical device – or associated software applications for the same – here are questions you’ll want to ask (any) software development vendor.

  1. What current certifications do you have
  2. Do you use a documented, validated compliant in-house QMS
  3. Do you have a Training Program
  4. How many Class I and II development efforts have you undertaken in the past two years
  5. How many Class I and II development efforts have you successfully completed on-time and within-budget in the past two years
  6. Which organizations will provide references for your Contract Manufacturing services

After your questions are (adequately) answered, here’s how to verify the vendor truly understands what a regulatory agency will expect.

Please show us (and explain) the following:

  1. Audit Summaries
  2. Compliance Matrix Experience:
    1. 21CFR Part 820
    2. ISO 13485:2016
    3. ISO 14971:2019
    4. IEC 62304:2015
  3. Intended Use Tool Validations
  4. Software Development Life Cycle Process Flows
  5. Hazard Analysis and Software DFMEA examples
  6. Software Change Management Procedure

When all your questions are answered to your satisfaction, and the vendor has provided at least 3 client references that you can directly confirm – then you have a much greater chance of project success with this vendor.

Why would we provide this list of questions – when Advantu also provides software engineering support?

That’s a great question, and here’s our best answer. Because it’s the right thing to do.

The Medical Device Industry is one of very few, which – if engineering/quality mistakes are made – human lives are at stake.  Much like the automotive, airline, and ship building industries – don’t forget civil engineers who design, build, test and repair bridges, high rises, etc. – there is no substitute for doing everything right, 100% of the time.

Advantu wants to land on the right side of history.   We continually employ techniques and provide information that helps medical device companies build safer, more reliable products (on a consistent, cost-effective basis) it’s in our best interest to do so.

We want our families, if/when they ever need to visit a doctor or hospital, to be able to completely trust the technology that contributes to their care.

Which means, if I can help a company – that I may never do business with – find the very best vendor for their new product…then I’ve done my part.

It’s the right thing to do.


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