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
• 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