Our People – Post Market Surveillance
✔ Post Market Surveillance · EU MDR · Engineering Excellence

The people behind
managecomplexity.

Regulatory expertise meets engineering depth. Meet the founder who navigates EU MDR for medical device companies – and the technical team that builds the tools to make it happen.

Founder
👩‍💼

Katharina
Socher-Wedel

Over 20 years at the intersection of medical device quality, regulatory compliance, and process excellence – built at Siemens Healthineers, now at the service of SMEs who refuse to let regulation stand in the way of good products.

  • EU MDR & Post Market Surveillance specialist
  • 250+ software versions & field actions guided
  • 12 M€ non-conformance costs reduced
  • Innovation Award 2018 for AI-driven quality processes
Read her story →
Engineering Team
⚙️

Creative minds.
Deep engineers.

More than 50 years of combined software engineering experience, hands-on medical device expertise, full OSI-stack networking knowledge, and a security-first culture rooted in ISO 27001.

  • 50+ years combined programming experience
  • OSI layers 1–7 · remote diagnostics
  • Advanced SQL & solid database architecture
  • ISO 27001 · security embedded by design
Meet the team →

Expertise that scales
with your ambition.

From startup to mid-size – we know your world.

20+
Years medical device experience
50+
Years engineering expertise
L1–L7
Full OSI stack coverage