I was in a similar spot about three years ago at a smaller med device company in Germany—suddenly we're getting inquiries from US partners and our CEO's like "yeah we're HIPAA compliant" and I'm sitting there like... are we though? It was genuinely stressful because it wasn't just about the tech stack, it was realizing how much operational stuff we'd been doing casually that would need to be actually documented and intentional.

Here's the thing that helped me: HIPAA and CSV sound scarier than they actually are when you break them down. HIPAA is mostly about access controls, encryption, and audit trails. CSV is just the EU's version of GxP requirements—it's pharmaceutical stuff but the principles overlap. Getting ISO 27001 certified is a genuinely smart move and honestly, most of the work you do for that will count toward both frameworks anyway, so you're not starting from zero.

The practical stuff I'd actually focus on right now: get your hands dirty with your current infrastructure and map out who has access to what. You're probably the only person touching a lot of systems, which is actually both good and bad—good because you know what's happening, bad because you need documented procedures so when you eventually hire people, they have clear guardrails. Document everything, even the stuff that seems obvious to you now. For the

Honestly, the on-prem vs cloud thing is less about where your data sits and more about who can actually *audit* it properly. If you're going for HIPAA compliance, you'll need solid logging and monitoring in place regardless — cloud providers usually have better built-in audit trails, but on-prem means you have tighter control if you set it up right. ISO 27001 is definitely a good starting point, but heads up that HIPAA and CSV have some specific requirements (like Business Associate Agreements, encryption standards, breach notification procedures) that go beyond what 27001 covers, so you'll need to layer those on top.