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Insights on compliance
SaMD compliance: a startup guide to FDA and EU MDR
Software as a Medical Device has different rules in the US and Europe, but the underlying compliance work is largely the same. Here is what you need to know before your first enterprise sale or regulatory submission.
Read more →When does software become a medical device in the EU?
If your app touches health data or clinical decisions, you have probably wondered this. The EU's answer comes down to one thing -- intended purpose.
Read more →AI and ML model compliance and what ISO/IEC 42001 means for your product
ISO/IEC 42001 is the new standard for AI management systems. If your product includes machine learning, here is what it asks for and how to get ahead of it.
Read more →Using AI for compliance is not cheating. It is exactly the point.
AI can generate requirements, suggest risk items, and structure your QMS from scratch. The standards allow it. Here is why AI-assisted compliance is legitimate, and what humans still need to do.
Read more →Compliance is not scary. Here is what it actually means.
"ISO 13485", "HIPAA", "IEC 62304" these words make founders nervous. They shouldn't. Compliance means following a set of rules and being able to prove it. Here is how it works.
Read more →A note from the founder: why I built QualiHQ
I was CTO of a diabetes AI company. Getting our QMS in place was one of the most frustrating experiences of my career. Not because compliance is hard, because the tools were terrible.
Read more →What is a QMS? A plain-English guide for software teams
No jargon, no consultants. Here is what a Quality Management System actually is, what the terminology means, and how SaaS teams use one.
Read more →The real cost of a QMS (and why most small companies can't afford it)
Greenlight Guru, Veeva, Qualio -- enterprise QMS platforms cost more than most startups can justify. Here is what a QMS should actually cost.
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