We’ve been the interim CTO responsible for getting a medical device through regulatory approval. That means we understand the process from the inside: the documentation requirements, the quality management systems, the clinical evaluation reports, the back-and-forth with notified bodies. When we advise on healthcare technology, it’s because we’ve done the work ourselves.

Software as Medical Device (SaMD)

SaMD is where software meets regulatory scrutiny, and getting it wrong is expensive. We’ve built SaMD products from concept through regulatory approval to post-market surveillance. That includes EU MDR compliance (and legacy MDD transitions), FDA 510(k) submissions, and the quality management systems (ISO 13485) and software development standards (IEC 62304) that regulators expect.

The challenge with SaMD goes beyond passing regulatory review—you need a development process that produces compliant products without grinding to a halt. We’ve figured out how to maintain development velocity while meeting documentation and traceability requirements. It’s possible; it just requires thoughtful process design.

Platform Engineering for Healthcare

Healthcare platforms have specific requirements: GDPR and HIPAA compliance, HL7/FHIR interoperability, integration with electronic health records, audit trails for everything. We’ve built systems that handle sensitive health data at scale, with the security architecture and compliance controls that European and US regulators require.

Performance matters too. We’ve delivered 500%+ improvements on healthcare platforms where response time affects clinical workflows. When clinicians are using your software during patient encounters, slow is not acceptable.

Digital Therapeutics and Remote Monitoring

Evidence-based digital therapeutics require clinical validation, reimbursement pathway navigation, and user experience design for patients who may not be technically sophisticated. Remote patient monitoring adds real-time data pipelines and alerting logic to the mix. We’ve built both, understanding the clinical requirements alongside the technical ones.

Healthcare technology requires both technical excellence and regulatory sophistication. Plenty of talented engineers have never been through an MDR certification or FDA submission; plenty of regulatory consultants don’t understand software architecture. We bring both.

Our background as interim CTO/CPO for medical device companies means we’ve dealt with the full picture: presenting to investors, managing clinical trials timelines, negotiating with notified bodies, building engineering teams that can work within regulatory constraints. We’ve sat in the chair, not just advised the person sitting there.

We’re based in Berlin with native German and English capabilities—useful for European regulatory processes and working with German-speaking clinical teams, notified bodies, and regulatory authorities.

The European market needs specialized SaMD expertise that combines regulatory knowledge with hands-on technical leadership. That’s what we offer.