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Client Communication - SaaMD company

tb3625

Starting to get Involved
#1
We are a SaaMD company and I've been asked to perform a regulatory assessment to understand exactly what we need to communicate to clients, specifically around:
• known issues and when any code moving to a client's Production environment. Do we have to notify clients of defects we found and resolved before the code was ever released in a client domain?
• level of detail in What's New - do we need to communicate all fixes specifically? (Think about how most apps say "general stability improvements" or whatever.) Is that sufficient?
• expectations of "certification guidelines" - ie - steps available for clients to test the new enhancement of defect correction

I've looked at the following with little success:
GHTF-SG1-N009R6 - Labeling for Medical Devices
Electronic Code of Federal Regulations - PART 820 QUALITY SYSTEM REGULATION
Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers
Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation
9001:2015
13485:2016
14971:2007
Medical Device Regulation


Is it merely what our QMS states we will communicate?
We have several cloud solutions which can release new code quickly. We don't want to overburden our clients with a lot of "noise" of defect corrections/enhancements that may not have any impact on current workflows.

What am I missing?

TIA
 
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indubioush

Quite Involved in Discussions
#2
Who asked you to perform a regulatory assessment?
What type of device do you manufacture (SaMD that generally does what)?
What regulatory path have you taken for your software device (FDA 510K, CE Mark, etc.)?
Who are your "clients"? Are they the end user?

Answer these questions and someone might be able to help you.
 

tb3625

Starting to get Involved
#3
We have multiple medical devices. 8 or so have 510(k) clearance and CE Mark. With EUMDR, another 80 or so solutons from our portfolio are now considered medical devices and we are actively working on our technical files for CE Mark for these.

Our "clients" are the IT and/or clinical staff at hospitals/clinics who use our software. Examples include PACS viewer and Fetal Monitoring solutions.
 

yodon

Staff member
Super Moderator
#4
ISO 62304 is the medical device software lifecycle standard. It says that you should "advise relevant parties of the existence of problems, as appropriate" - which leaves the door open a bit more than you'd like, probably. I would suggest:

• known issues and when any code moving to a client's Production environment. Do we have to notify clients of defects we found and resolved before the code was ever released in a client domain?
I would suggest documenting all known issues. Issues found / corrected before distribution wouldn't need to be reported (but see next point).

• level of detail in What's New - do we need to communicate all fixes specifically? (Think about how most apps say "general stability improvements" or whatever.) Is that sufficient?
This will depend on your customers' needs. They may NEED to know of all changes with sufficient detail to know if they need to take subsequent actions (any internal validation) - especially if your software has interfaces with other equipment / other software (which may vary in revision levels).

• expectations of "certification guidelines" - ie - steps available for clients to test the new enhancement of defect correction
Again, probably something based on your customers' needs.

We have several cloud solutions which can release new code quickly. We don't want to overburden our clients with a lot of "noise" of defect corrections/enhancements that may not have any impact on current workflows.
Information is a balancing act; however, your customers may, as indicated above, need to know when changes are pushed out. They may have internal acceptance policies. Definitely talk to them to understand their needs / limitations. You may need to just give a "heads up - we're rolling out the next release on dd-mm-yy" kind of notice or you may need to make the release available where they can get it and install at their convenience.

A couple of follow-on points:
  • If your software incorporates "SOUP" (Software of Unknown Provenance; i.e., off-the-shelf libraries, etc.) you'll want to monitor that for any known issues and corrections.
  • Cybersecurity is a focus area - UL-2901 provides some guidance on documentation your customers may want / need.
 
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