01.08.2026 aktualisiert
100 % verfügbar
MDR · AI Act · ISO 14971 · Risk Management · QMS | Helping Digital Health Startups get EU CE Marking
Vechelde, Deutschland
Weltweit
M.Sc., Thesis Submitted for Dr. Ing. in Digital Health - Connected Healthcare (Awaiting Defense)Über mich
Most digital health startups hit the regulatory wall too late. I help SaMD and SiMD teams understand their MDR roadmap and achieve CE marking without costly surprises from a Notified Body.
Skills
AI AgentsKünstliche IntelligenzMedizinische SoftwareIec 62304Iso 13485ISO 14971Medizinprodukten
Most startups realize too late: getting a digital health product from concept to CE mark is as much a regulatory journey as a technical one.
I help digital health startups and SMEs building Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD) understand exactly what stands between their product and CE marking, and how to get there without unnecessary detours or costly surprises from a Notified Body.
My background combines a bachelor's and a master's in computer science with five years of PhD research at the Hasso Plattner Institute in digital health, including navigating five self-initiated ethics applications, clinical study design, GDPR-compliant data collection, and building validated digital biomarkers from 500+ hours of real-world wearable data. That work has been published in Nature Scientific Data and recognized with a Best Paper Award at eTELEMED 2024. This means I speak both the technical and the regulatory language fluently, and it matters especially when your team is full of engineers who've never written a risk management file.
In essence, my services cover gap assessments toward CE marking and Notified Body audit preparation, letting you know what's missing before an auditor tells you. In detail, this means:
• Compliance advisory: ISO 14971, ISO 13485, EU MDR 2017/745, and the EU AI Act
• Regulatory writing: risk management plans and files, hazard traceability matrices, clinical evaluation reports, post-market surveillance plans, technical files, and design history files
• Software lifecycle compliance: IEC 62304, SOUP management, and SaMD/SiMD documentation
I focus on early-stage and growth-phase companies because that's where regulatory strategy has the highest leverage and where a pragmatic, cost-effective partner makes the biggest difference.
If you're building a medical-grade digital health product and want to understand your MDR roadmap, let's talk!
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Additional skills and experience:
SQL & Data Modeling
SQL and data modeling for managing and querying structured datasets in research and production environments.
Python & Machine Learning
Deep expertise in Python with extensive use of NumPy, SciPy, Scikit-Learn, TensorFlow, and PyTorch for developing machine learning models (SVM, k-NN, logistic regression) and deep learning architectures (CNNs, GANs, LSTMs) applied to complex physiological and time-series data.
Advanced Statistical Analysis & Signal Processing
Proficiency in advanced statistical inference methods, including linear regression, ANOVA, and hypothesis testing.
Containerization & CI/CD Pipelines, Cloud Computing, and Distributed Computing
Hands-on experience with Docker, Kubernetes, and Jenkins for containerization, orchestration, and continuous integration and deployment pipelines in software engineering projects. Experience with cloud computing platforms and distributed computing for scalable data processing tasks.
Erfahrung
Berufserfahrung5 - 10 Jahre
Freelancer seit2026
Sprachen
DeutschMutterspracheEnglischverhandlungssicherFranzösischGrundkenntnisseSpanischgut
Projekthistorie
Providing regulatory affairs and technical consulting to digital health startups and SMEs developing Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD) seeking CE marking under EU MDR 2017/745.
Services include:
▸ Gap assessments toward CE marking and Notified Body audit preparation
▸ Regulatory writing: risk management plans and files, hazard traceability matrices, clinical evaluation reports, post-market surveillance plans, technical files, and design history files
▸ Software lifecycle compliance: IEC 62304, SOUP management, and SaMD/SiMD documentation
▸ Compliance advisory across ISO 14971, ISO 13485, EU MDR 2017/745, and the EU AI Act
▸ Technical advisory: software architecture review and implementation guidance for regulated digital health products
• Regulatory Data Governance & Ethics Compliance: Led five separate ethics applications to full 0-1 approval at major institutions, establishing legal and ethical frameworks for clinical data collection. Direct hands-on experience with the data governance backbone of MDR technical documentation through architecting GDPR-compliant data acquisition pipelines.
• Clinical Study Design & Validation: Designed and ran clinical studies collecting 500+ hours of real-world wearable sensor data (EEG, PPG, EDA), applying rigorous statistical validation (ANOVA, hypothesis testing) to produce evidence suitable for clinical evaluation and regulatory submission.
• Explainable AI for Clinical Trust: Built and validated ML and DL models (CNNs, GANs, LSTMs) for physiological signal classification, prioritizing explainability to medical doctors to build clinical trust, a core requirement for AI-based SaMD under the EU AI Act.
• Cross-Functional Communication & Mentorship: Bridged technical and clinical/scientific stakeholders throughout four multidisciplinary research projects; supervised six Master’s students and mentored three on regulatory-adjacent topics, including data governance and study design.
• Technical Documentation & Publication: Authored peer-reviewed technical documentation and scientific reporting, demonstrating the same rigor required for MDR technical files. Published in Nature Scientific Data and recognized with a Best Paper Award at eTELEMED 2024.
• Conducted literature research and synthesized scientific findings to scope a new study on neurological disorders (epilepsy), establishing the initial ethical and regulatory framework for subsequent clinical data collection.