01 / 06
System & Program Leadership for Complex Regulated Medical Systems

From architecture to approval –
leading regulated systems to success.
MedTech focus.

I bridge engineering and business –
so systems reach approval safely and efficiently.

Dr.-Ing. Stefan Trapp
System Architecture · Platform Strategy · MedTec · AI Innovation
Schedule a Call ↗
25+
Experience
> 50 FTE
R&D Programs
ATO
Approvals
MDR · FDA · DoD RMF
Regulatory
"Delivered on all deadlines under the most challenging conditions — consistently exceeding expectations."
– Philips Healthcare
02 Services

I step in when programs stall:

How I get programs back on track:

What I deliver:

Program leadership and stabilization

Taking responsibility when delivery, quality or timeline are at risk.

Interim Management Platform Delivery Multi-Site (>50 FTE) Targeted Decisions

Scalable and
compliant software
systems

Structuring complex software systems – for scale, quality, and regulatory approval.

Regulated Systems Medical Software Scalable Architecture Java, C#, Python Quality & Automation

Integrating regulation safely

Integration of MDR, FDA, and cybersecurity requirements into systems and development processes.

MDR / FDA ISO 13485 / 14971 Cybersecurity (RMF) IEC 62304 / 60601

MBSE and AI-based technology planning

Roadmapping based on MBSE technology analysis and AI-supported application and solution discovery.

Technology Planning MBSE / SysML AI Solution Search AI Application Search
03 Mandates

When things get critical, I take responsibility.

Three selected mandates in critical programs.

01

Global software platform delivered to release

Responsible for a global multi-site software platform (>50 FTE, Europe & India) in X-ray diagnostics.

On-time release despite company restructuring and COVID-19.

Philips Healthcare DXR
Eleva Platform
CombiDiagnost
02

First-ever ATO approval achieved at US DoD

Implemented cybersecurity requirements throughout the development process.

Philips DXR obtains first-ever Authorization to Operate (ATO) for its systems.

Philips Healthcare DXR
Eleva Platform
DigitalDiagnost
ProxiDiagnost
03

PLM kept stable despite global relocation

Maintained stable PLM structures and ensured regulatory traceability across sites.

Philips Healthcare DXR
MammoDiagnost DR
MammoDiagnost AR
"He proactively addressed all challenges – including unexpected ones – developed effective solutions quickly, and executed them successfully."
– Philips Healthcare
04 Profile

What I bring to the table

I combine engineering, business and strategy – delivering programs reliably to completion.

Experience & Responsibility

  • Senior consultant and interim manager for complex, regulated systems
  • 25+ years of experience developing safety-critical medical systems
  • Leading international programs and teams (>50 FTE)
  • End-to-end responsibility from architecture to release and regulatory approval
  • Integration of regulatory requirements into development (US DoD RMF incl. ATO)
Technologies & Methods
  • System and software architecture (MBSE, SysML, UML)
  • Modern software development (Java, C#, Python, CI/CD, DevOps, Test Automation, Verification, Traceability)
  • Agile and classical development processes (incl. scaling)
  • AI-powered systems (NLP, LLM integration, vector databases)
  • Quality & lifecycle management (e.g. TrackWise EQMS, PTC Windchill)
  • Medical imaging: X-ray diagnostics (DR, CR, mammography), DICOM, PACS
Degrees
Dr.-Ing. – Technology and Innovation Management Industrial Engineering and Management (Dipl.-Ing. oec.) Electrical and Computer Engineering (Dipl.-Ing.)
Certifications
OMG® Certified Systems Modeling Professional (OCSMP) IPMA Level D®, certified 2013–2023 Certified SAFe® 5 Program Consultant (SPC, 2021)

Publications

View all →

Selected articles on AI, systems engineering and cybersecurity in regulated MedTech environments.

2024 LLM-based Extraction of Contradictions from Patents TRIZ Future Conference
2023 Question Answering with Transformers and Few-Shot Learning TRIZ Future Conference
2021 Medical Device Cybersecurity MED engineering
Contact

Tell me what's going on – 20 minutes is enough to see whether I can help.

Available for mandates