Kolabtreeを選ぶ理由

開始はすばやく簡単です。初期費用はかかりません。

サービス依頼と専門家への見積依頼は無料です。

Kolabtree の作業範囲に同意する前に、専門家と要件を詳しく相談できます。

専門家と直接連携し、必要な成果を正しく得られます。

専門家を採用したらプロジェクトに資金を入れ、作業完了後に成果物を承認できます。

Christoph P. に連絡

連絡する

Kolabtreeを選ぶ理由

この専門家をプロジェクトに採用したいですか？見積もりを依頼無料で。

プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Dr. Christoph P.に依頼

Germany

EU MDR · SaMD · ISO 14971 · Risk Management · QMS · EU AI Act | Helping Digital Health Startups Navigate CE Marking

プロフィール概要

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 xxxxxxxx, 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!

###

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.

専門分野

サービス

Writing
Research
Consulting
Data & AI
Product Development

Writing Medical Writing, Non-Medical Regulatory Writing, Technical Writing, General Proofreading & Editing

Research Feasibility Study, Technology Scouting, Fact Checking, Gap Analysis, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Go-to-Market Strategy Consulting, Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Data & AI Predictive Modeling, Statistical Analysis

Product Development Product Compliance , Concept Development

職務経験

Hasso Plattner Institute

- 現在

Freelance Regulatory Affairs and IT Consultant

Christoph Anders IT Beratung

3月 2026 - 現在

Senior Backend Engineer an PhD Researcher on Data-Driven Engineering, Advanced Analytics and ML

Hasso Plattner Institute

4月 2021 - 11月 2025

Data Analyst for Healthcare Compliance

Hasso Plattner Institute

6月 2020 - 7月 2020

Scientific researchers

Charité University Hospital

1月 2020 - 7月 2020

Student Assistant for Statistical Analysis for Gene Selection

Hasso Plattner Institute

4月 2019 - 6月 2019

Backend Engineer for Microservices Migration

Hasso Plattner Institute

4月 2018 - 10月 2018

System Analyst and Software Developer

GOD Gesellschaft für Organisation und Datenverarbeitung mbH

12月 2016 - 10月 2017

IT Specialist Application Development

GOD Gesellschaft für Organisation und Datenverarbeitung mbH

9月 2013 - 12月 2016

学歴

Doctor of Engineering

Hasso Plattner Institute

4月 2021 - 現在

Master of Science

Hasso Plattner Institute

10月 2017 - 3月 2021

Bachelor of Science

Ostfalia University of Applied Sciences

9月 2013 - 12月 2016

High School Diploma

Julius-Spiegelberg Gymnasium

8月 2000 - 7月 2012

認定資格

EU MDR Practitioner Training

Comply Guru
https://complyguru.com/en-us/check-certificate/?certificate_no=6930
6月 2026 - 現在
Risk Management for Medical Devices

Medical Device HQ
https://www.credential.net/a1c10f4f-2b28-416b-ab36-110be417495a
6月 2026 - 現在

出版物

BOOK CHAPTER

Christoph Anders, Sidratul Moontaha, Samik Real, Fabian Stolp, Bert Arnrich (2026). Multi-modality Improves Cognitive Load Classification of Naturalistic Tasks Under Varying Signal Quality .

JOURNAL ARTICLE

Sidratul Moontaha, Constanze Cavalier, Birgitta Esser, Arthur Jordan, Ines Goebel, Christoph Anders, Afsana Mimi, Björn Krüger, Rainer Surges, Bert Arnrich (2025). EPIStress: A multimodal dataset of Physiological signals to measure cognitive stress in epilepsy patients . Scientific Data.

Christoph Anders, Sidratul Moontaha, Samik Real, Bert Arnrich (2024). Unobtrusive measurement of cognitive load and physiological signals in uncontrolled environments . Scientific Data.

Christoph Anders, Gabriel Curio, Bert Arnrich, Gunnar Waterstraat (2023). Optimization of data pre-processing methods for time-series classification of electroencephalography data . Network: Computation in Neural Systems.

Wearable electroencephalography and multi-modal mental state classification: A systematic literature review <head> <META HTTP-EQUIV="Refresh" CONTENT="0;URL=/servlet/useragent"> </head> . Computers in Biology and Medicine.

Christoph Anders, Christoph Anders, Christoph Anders, Christoph Anders, Christoph Anders, Christoph Anders, Christoph Anders, Christoph Anders, Christoph Anders, Christoph Anders, et al.(2022). Wearable electroencephalography and multi-modal mental state classification: A systematic literature review . Computers in Biology and Medicine. Microsoft.AspNetCore.Mvc.Localization.LocalizedHtmlString 106088. Elsevier {BV}

level-one heading

EU MDR · SaMD · ISO 14971 · Risk Management · QMS · EU AI Act | Helping Digital Health Startups Navigate CE Marking

Hasso Plattner Institute

Freelance Regulatory Affairs and IT Consultant

Christoph Anders IT Beratung

Senior Backend Engineer an PhD Researcher on Data-Driven Engineering, Advanced Analytics and ML

Hasso Plattner Institute

Data Analyst for Healthcare Compliance

Hasso Plattner Institute

Scientific researchers

Charité University Hospital

Student Assistant for Statistical Analysis for Gene Selection

Hasso Plattner Institute

Backend Engineer for Microservices Migration

Hasso Plattner Institute

System Analyst and Software Developer

GOD Gesellschaft für Organisation und Datenverarbeitung mbH

IT Specialist Application Development

GOD Gesellschaft für Organisation und Datenverarbeitung mbH

Doctor of Engineering

Hasso Plattner Institute

Master of Science

Hasso Plattner Institute

Bachelor of Science

Ostfalia University of Applied Sciences

High School Diploma

Julius-Spiegelberg Gymnasium

EU MDR Practitioner Training

Comply Guru

Risk Management for Medical Devices

Medical Device HQ