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Regulations like 62304 and ISO-13485 are specifically designed to stop ideas going to prod in a few hours. HIPPA is something completely different. HIPPA is mu
by sjducb 3y ago
Regulations like 62304 and ISO-13485 are specifically designed to stop ideas going to prod in a few hours.
HIPPA is something completely different. HIPPA is much more lightweight.
Probably your company has found a niche that manages to avoid requiring compliance with medical devices regulations. This is a great idea and it lets you make very good software quickly.
- beaugunderson 3y ago*HIPAA (sorry, I'm in healthcare and it makes my eye twitch)
- kakoni 3y agoBoth of these regulations you mentioned are indeed valuable when doing medical software development in EU (mdd/mdr). However, in US, these giant EHR systems (epic, cerner etc) are not regulated by FDA.
- bick_nyers 3y agoSpeaking from the perspective of healthcare software: ISO-13485 really isn't that heavy in the grand scheme of things. Once you establish your policies you can automate most of it with Jira, which can provide good traceability. It's really the testing requirements that are the most heavy, and whether you can do that in a few hours is 100% up to how good your testing setup is. I suspect that the quality management system is often this way at any mature tech company anyways, but who knows. When you need to perform a 510k, that's where the heaviness comes into play, even a special 510k can be considered heavy. For those uninitiated, here's the FDA guidance on when to perform a 510k: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-software-change-existing-device https://www.fda.gov/regulatory-information/search-fda-guidan... Rewriting a core piece of your software stack in a significantly different language is one such case (JavaScript to TypeScript? Probably not. Java to C++? Most certainly yes.).