Software Boutique for Software as a Medical Device
Product strategy and engineering. Aligned by people who care about the outcome.
We don't bolt compliance on at the end — we engineer it in from day one.
Our Vision
Healthcare is becoming more personal — home diagnostics, digital therapeutics, AI-powered screening. The software behind it must be as reliable as the medicine itself. We build the engineering foundation for that future.
Our Mission
We accompany diagnostics and digital health companies from product idea through certification to market — with regulatory competence in every sprint. Technical depth and compliance, never one without the other.
What sets us apart
Product thinking paired with engineering execution. Senior SaMD engineers rooted in diagnostics — not a generic agency. We know the regulatory landscape, think system-wide, and stay from first commit through lifecycle support.
Trusted by
Our experience is built on
- 30+
- Projects in the medical domain
- 10+
- Years of regulated software development
- 5+
- Regulatory markets
IVD-R Home Use certification in 4 months — from decision to TÜV Rheinland approval.
hey mela · Phaeosynt GmbH
Where are you right now?
Not sure? Talk to us — we'll figure it out together.
"We have a product idea — but no regulated software team."
We build it with you, from regulatory strategy to certified product.
New product development →"Our device works. Now we need software around it."
We integrate into your existing QMS and regulatory framework.
Digital extension →"We're building — and want to make sure our documentation and processes are audit-ready."
We align your documentation and processes with IEC 62304 and ISO 14971 — so you're ready when the auditor arrives.
Regulatory alignment →"Our product is live. We need ongoing change management and regulatory maintenance."
Change impact analysis, risk reassessment, verification of updates, documentation maintenance, and post-market surveillance support.
Lifecycle support →"We have a team — but want an independent check before we submit."
Focused architecture and documentation reviews. No strings attached.
Talk to us →Book a free introductory call — we'll discuss your project and outline actionable next steps.
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