EU MDR · EU AI Act · SaMD · ISO 14971 · Risk Management · QMS | Helping Digital Health Startups Navigate MDR & CE Marking
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- 10439 Berlin
- Weltweit
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- 06.07.2026
- Contract ready
Kurzvorstellung
Geschäftsdaten
Qualifikationen
Projekt‐ & Berufserfahrung
3/2026 – offen
Tätigkeitsbeschreibung
• 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, risk management and its documentation (ISO 14971), regulatory writing (clinical evaluation reports, hazard traceability matrix, technical files, design history files), software lifecycle compliance (IEC 62304), and Notified Body audit preparation.
Kundenberater, Risikoanalyse, Medizintechnik, Regulatory Affairs
4/2021 – 11/2025
Tätigkeitsbeschreibung
• 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.
Backend Entwickler, Continuous Delivery, Continuous Integration, Datenanalyse, DevOps, E-Learning, Java (allg.), Machine Learning, Projektmanagement, Python, SQL
6/2020 – 7/2020
Tätigkeitsbeschreibung• 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.
Eingesetzte QualifikationenDatenanalyse, Forschung
1/2020 – 7/2020
Tätigkeitsbeschreibung• Planned and secured ethics approval for a clinical study on high-frequency somatosensory evoked potentials; engineered the measurement software and hardware integration, demonstrating end-to-end ownership from ethics approval through technical execution.
Eingesetzte QualifikationenDatenanalyse, Projektmanagement (IT), Python
4/2019 – 6/2019
Tätigkeitsbeschreibung• Implemented statistical gene-selection methods on high-dimensional genomic data using R, integrating novel approaches into an existing research framework.
Eingesetzte QualifikationenDatenanalyse, Java (allg.), Python, R (Programmiersprache), SQL, Statistiken
4/2018 – 10/2018
Tätigkeitsbeschreibung
• Explainable AI for Risk Assessment: Gathered structured feedback from medical professionals on saliency-map explanations of a complex RNN-GAN model, gathering direct experience communicating black-box model risk to clinical stakeholders.
• Containerized software deployment (IEC 62304), relevant to SaMD software lifecycle documentation, demonstrated through migration of a microservice-based system using Docker, REST, and JSON.
Backend Entwickler, Datenanalyse, Docker, Generative KI, Java (allg.), Machine Learning, Python
12/2016 – 10/2017
Tätigkeitsbeschreibung• Supported maintenance of a corporation-wide Java application, ensuring code quality through rigorous testing (JUnit) and CI/CD integration in a production environment.
Eingesetzte QualifikationenBackend Entwickler, Continuous Delivery, Continuous Integration, Datenanalyse, Java (allg.), Jenkins, Linux-Systemadministrator, Scrum, SQL, Testen
9/2013 – 12/2016
Tätigkeitsbeschreibung• Developed in-house and customer projects using C++, Java, Python, and SQL, building a strong cross-language software engineering foundation.
Eingesetzte QualifikationenBackend Entwickler, C++, Continuous Delivery, Continuous Integration, Datenanalyse, Java (allg.), JavaScript, Jenkins, Linux-Systemadministrator, Postgresql, Projektmanagement (IT), Python, Representational State Transfer (REST), SQL, Webentwickler
nicht angegeben
9/2012 – 8/2013
Tätigkeitsbeschreibung
nicht angegeben
7/2012 – 9/2012
TätigkeitsbeschreibungEingesetzte Qualifikationen
Linux-Systemadministrator
Ausbildung
Hasso Plattner Institute
Potsdam, Germany
Hasso Plattner Institute
Potsdam, Germany
Ostfalia University of Applied Sciences
Wolfenbüttel, Germany
Julius-Spiegelberg Gymnasium
Über mich
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!
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Spanisch (Gut)
- Französisch (Grundkenntnisse)
- Europäische Union
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