EU MDR Experts in Germany
with fast, precise AI matching from over 15,000 CVsHire experts who guide medical device classification, technical documentation, clinical evaluation and post-market surveillance. FRATCH matches you quickly with vetted, available freelancers whose EU MDR experience fits your product and regulatory scope.
Meet FRATCH Experts in Germany, who have recently used EU MDR
Rüdiger S.
Last position:
Manufacturer of busbar systems for power and data transmission
- Review and assessment of the existing situation
- Identification and definition of implementation measures to close existing gaps
Jens-Uwe P.
Last position:
Architecture and Programming for Automotive Test Bench Platform at Automotive Supplier
In this project, I was responsible for the design and implementation of a new, modular, and highly scalable test bench platform for an automotive supplier. My focus was on developing a robust system architecture and programming the associated software, with consistent use of UML modeling throughout. This structured approach made it possible to greatly increase the reusability of individual LabVIEW test modules and to significantly reduce development time for follow-up projects. I also integrated modern automotive standards such as CAN FD, LIN, and safety requirements, which made the solution future-proof.
Technologies: LabVIEW, Visio, UML, CAN FD, LIN, DMM, Safety, image processing, project management, HMI, C#, C++, Python, Rust, CI
Steffen E.
Last position:
Domain Lead FI, CO, HR, Investor Relations at Douglas Group
- Process Owner SAP ERP 8 FI, CO & Investor Relations
- Process Owner SAP Success Factors
- Responsible for 4 teams, 39 FTE
- Full responsibility for end-to-end processes in SAP for Finance, Controlling, HR, Investor Relations
- Interface to certified public accountants for Finance IT (KPMG)
- ITIL-4 implementation for service request change request and project management with Service Now (Project Manager)
Melanie S.
Last position:
Lead Quality / Regulatory at Confidential
Built and drove the implementation of an ISO 13485-aligned quality management system for a newly established medical-device manufacturer developing products for leading OEM customers. Led RA/QA strategy, QMS architecture, design-control setup, supplier-...
Kurt F.
Last position:
WeMatch Consulting GmbH / Contracting / Framework agreement - Novanta Medical GmbH
- Labeling BarTender
- Structure, Schema ST4 consulting.
- MDR consulting.
Andreas S.
Last position:
Consulting on quality management and regulatory affairs at Curevius GmbH
Manufacturer of medical devices
- Creation and further development of quality management systems according to EN ISO 13485
- Gap analysis of existing quality management systems according to ISO 13485
- Consulting and support in customer projects in the field of quality management and
- Proof of regulatory compliance for medical devices of all risk classes
- Preparation of technical documentation according to MDR
- Gap analysis of the risk management file according to ISO 14971:2019
Stephan F.
Last position:
Consultant at Toolmaking
The project covered the introduction of SAP S4HANA including EWM. The customer manufactures tools for the international market, with 300 production orders and 2,000 shipments to be processed every day. The project started with the "Explore phase," where the target business and SAP processes were defined, and ended with reaching the productivity goals with S4HANA. My role was Key User Trainer and optimizing the live processes.
Denys Z.
Last position:
Technical Writer at Omilia Natural Solutions
- Creation of technical documentation for conversational AI products
- Development of user and API manuals (JSON, Markdown)
- Use of Git, Jira, Confluence for version control and task tracking
- Collaboration with engineers and PMs for accurate content
Armin W.
Last position:
Interims Head of Functional Safety & R&D Processes at SEMIKRON Danfoss GmbH & Co KG
- Planning and coordination of all safety activities and organizational development to meet the requirements of ISO 26262 and IEC 61508
- Process development according to Automotive SPICE™ and ISO 26262
- Establishment and technical leadership of the CoC Functional Safety Management and coordination and responsibility of safety activities across all projects (ASIL C and ASIL D)
- Stakeholder management and alignment with OEMs, DIA/RASIC coordination
- Steering of staff on developing functional safety and relevant work products for safety evidence
- Planning, coordination, monitoring and progress analysis of work package creation and action tracking
- Planning and execution of safety assessments and audits for internal sub-projects and external suppliers
- Creation of the safety plan and support in creating work packages for the safety case
- Conducting FMEAs, FMEDAs and FTAs
- Coordination, development and execution of safety training
- Resource and deployment planning, budget planning and controlling
- Planning, tendering, contracting and coordination of temporary external support services
- Interdisciplinary planning and coordination of activities in functional safety management according to ISO 26262
- Conducting ASPICE™ maturity assessments and deriving process improvements based on the standard requirements
- Planning, coordination and creation of the safety assurance documentation
- Central point of contact for functional safety for all organizational levels as well as NBs, OEMs and suppliers
- Reporting to the division manager
Alexander D.
Last position:
Interim Manager Procurement | Head of Procurement & Strategic Sourcing at Löwenstein Medical Technology GmbH & Co. KG
- Overall responsibility for strategic and operational procurement, Procurement Management (11 FTE).
- Further development of the procurement and procurement organization, including task and role model.
- Management of cross-functional special projects (e.g. value engineering, design-to-cost).
- Development and implementation of a holistic sourcing and procurement strategy with a focus on resilience, ESG, de-risking, decoupling and cost performance.
- Execution of a comprehensive procurement transformation with a new supply chain strategy alignment.
- Reorganization of the procurement team to improve efficiency through clear role allocation and relief from non-core and non-functional tasks.
- Professionalization of contract management processes and supplier development programs.
- Process optimization along the S2C and P2P chain, including standardization and automation in line with MDR (EU Regulation 2017/745), GxP compliance & quality management systems ISO 9001 and ISO 13485.
- KPI development and optimization of the KPI system for performance and efficiency measurement in critical paths and missing parts.
- Coaching the team in strategic procurement work, project management and procurement due diligence.
- Implementation of AI-supported tools for sourcing, spend analysis and inventory management to optimize inventory.
- Achieved inventory reduction of ~31% through professional inventory management.
- Management of two cost reduction (cost avoidance) programs with quantified results: ~50% reduction in manufacturing costs for one core component and ~64% reduction in material costs for the successor platform through redesign and category sourcing.
- Savings in the low double-digit million range versus the baseline.
- Material groups: contract manufacturing, PCBA, EMS, blower, silicone injection molding, power supplies, batteries, displays, hoses, masks, valves, foams, cables, sensors, wireless modules (2G–5G), telemedicine components, laboratory services.
Gregor P.
Last position:
Engineering Data Management Project Manager
Technical and commercial risk assessment for an investment project in the hardware sector (scaling potential, liability risks, operational processes) Process consulting for two SMEs in the engineering environment, focusing on workflow digitization, PLM
Maher K.
Last position:
Executive Management, Managing Partners at HMM Diagnostics GmbH
- Detailed information in the reference projects file
- Responsibility for the strategic and operational management of the company
- Leading and coordinating product development projects in the areas of e-health and medical technology
- Freelance project management activities in various industries, including IT and medical technology
- Introduction of innovative products and solutions in medical technology, connectivity and fitness in international markets
- Building platforms for e-health and corporate health management
- Introduction and migration of ERP systems (SAP Business One, JTL WaWi) in sales- and production-oriented companies
- Project management for international and cross-company projects
- Crisis management and successful control of critical projects
- Support of IT infrastructure including server landscapes and SAN systems
- Consulting for international company founders
Unnikuttan V.
Last position:
Managing Director (Co-Founder) at AathmaSignals
- Spearheading investor outreach and partnership development as founding MD, building the business case and technical narrative needed to attract initial funding and strategic collaborators in the digital health space
- Designing multi-agent AI systems for autonomous biosignal analysis, orchestrating LLM-based reasoning pipelines with domain-specific medical context to enable intelligent, clinical decision support
Peter S.
Last position:
Project Manager Camera Systems/Lenses at S&E Consulting Peter Sperber
- Management of internal and external optics, electronics, and software developers and the subproject managers throughout the entire development process up to handover to production
- Conducting RfP and contract negotiations with German, Chinese, and Japanese manufacturers and tracking the agreed deliverables
- Conducting quality gates throughout the development process
- Responsibility for meeting commercial, technical, and schedule requirements (resource and budget planning)
- Continuous monitoring of potential project risks during all phases
- Ensuring compliant development (RoHS & REACH) and documentation for worldwide CE marking
- Project status reporting to upper management and the company board
- Central point of contact for third-party contractors and their coordination in the project
Dirk W.
Last position:
General Management Consultant at Start-up in the e-commerce sector
- created a comprehensive business plan for investor meetings
- developed strategy, legal frameworks, partner selection processes, and planned operational processes and risks using AI tools
- mediated between the owner and the team
Discover over 15,000 top freelancers
Statistics of experts using EU MDR
Aggregated from the professional profiles of matched freelancers.
Experience
23 years
Position duration
3.3 years
Positions per freelancer
13
Top business areas
Quality Assurance, Product Development, Project Management
Top industries
Healthcare, Manufacturing, Information Technology
Certification focus areas
Quality Assurance, Project Management, Information Technology
Bachelor's degree or higher
90%
Master's degree or higher
48%
Doctorate
15%
Certifications per freelancer
6
Most common languages
German, English, French
Speak two or more languages
100%
Based on our profile pool as of 19 Sep 2026.
Daily rate distribution
The chart shows how the daily rates of freelancers in this technology in Germany are distributed, based on recent contracts on our platform. Each bar covers a rate range — its height shows how many freelancers charge within that range.
Average rates of experts in Germany using EU MDR
Rates are based on recent contracts and do not include FRATCH margin.
The average daily rate is the mean of all daily rates from recent contracts of comparable freelancers on our platform.
The median daily rate is the middle value of all daily rates — half of comparable freelancers charge less, half charge more. Unlike the average, it is barely affected by outliers.
Calculated based on our freelancers’ daily rates as of 19 Sep 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
EU MDR experts industry focus
See which industries our matched freelancers work in most often — every figure is calculated live from the freelancers on FRATCH.
- Healthcare (96%)
- Manufacturing (72%)
- Information Technology (45%)
- Pharmaceutical (43%)
- Automotive (40%)
- Professional Services (40%)
- Energy (36%)
- Biotechnology (28%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
What EU MDR covers
EU MDR is the European Union Medical Device Regulation that governs medical devices placed on the European market. It replaced the Medical Devices Directive framework and sets requirements for classification, conformity assessment, clinical evidence, labeling, registration and post-market obligations. Its scope can include software, accessories and connected products when they meet the definition of a medical device.
Classification and conformity
EU MDR specialists assess the intended purpose, risk class and applicable conformity route for a product. They translate product functions into regulatory claims, identify relevant standards and coordinate work with notified bodies where required. Strong professionals distinguish medical devices from in vitro diagnostics and from products that fall outside the regulation.
- Define intended purpose and device classification
- Map conformity assessment and quality requirements
- Prepare evidence for notified body review
Documentation and evidence
A compliant technical file connects design inputs, risk management, verification, validation and clinical evaluation. Specialists often work with ISO quality systems, usability engineering, software lifecycle controls and cybersecurity evidence. They also shape labeling, instructions for use and the declaration of conformity so that the record supports the product claims.
Where companies use it
EU MDR expertise appears across diagnostics, surgical equipment, monitoring systems, digital health products and medical software. Companies may need support during a new product launch, a transition from the former directive framework, a portfolio review or a notified body audit. In Germany, collaboration may involve local quality, regulatory and product teams alongside remote specialists across Europe.
- Prepare a new device for market access
- Remediate gaps in an existing technical file
- Align clinical evaluation with product claims
- Establish post-market surveillance processes
When to bring in specialists
Freelance support is useful when internal teams face a complex classification decision, compressed submission work or changing product scope. It can also help when a company needs an independent review before an audit, wants to resolve notified body questions or must connect regulatory work with engineering and quality processes. German-language collaboration may matter for local documentation and stakeholder communication, while many regulatory deliverables are prepared in English.
What strong professionals bring
The best EU MDR professionals combine regulatory judgment with practical knowledge of product development. They can challenge unsupported claims, trace every requirement to objective evidence and keep decisions consistent across technical, clinical and quality records. Look for clear examples of device classification, technical documentation, clinical evaluation, risk management and post-market work that match your device type and market route.
Frequently asked questions
Need clarity? These are the questions we hear most often about EU MDR.
EU MDR sets the rules for placing medical devices and certain software products on the European market. It covers classification, conformity assessment, clinical evidence, technical documentation, labeling, registration and post-market surveillance.
EU MDR generally requires a more structured evidence base, stronger traceability and broader post-market responsibilities than the former directive framework. It also gives greater regulatory weight to certain software products and introduces more detailed expectations for clinical evaluation and economic operator oversight.
A strong EU MDR specialist often works across ISO quality management, ISO risk management, clinical evaluation, usability engineering and software lifecycle controls. Knowledge of cybersecurity, post-market surveillance, technical writing and notified body interactions is also valuable for connected or software-based devices.
The required depth depends on the device class, novelty, clinical claims and conformity route. For a technical file review, focused regulatory experience may be enough; a new or high-risk product usually needs a professional who has led classification, evidence planning and submission preparation for comparable devices.
EU MDR work is often suitable for remote collaboration because documents, reviews and evidence workflows are digital. On-site sessions can still help with design reviews, production processes or audit preparation, while German-language communication may be useful when coordinating with local teams and authorities.
Engage an EU MDR freelancer before finalizing product claims or locking the technical documentation. Early involvement can prevent classification errors and evidence gaps; targeted support is also useful before a notified body review, portfolio transition or post-market system launch.
Ask the EU MDR professional to explain how they reached a classification decision and how each claim is supported by evidence. Review their experience with comparable device types, technical files, clinical evaluation, risk management and audit findings rather than relying only on regulatory terminology.
For German companies, EU MDR work must fit European market requirements while aligning with local quality, production and clinical stakeholders. A suitable specialist should understand notified body interaction, German business communication where needed and the practical coordination of regulatory work across distributed teams.
The average hourly rate of freelancers in Germany who have used EU MDR in their recent projects is 111 €, which corresponds to a daily rate of about 890 € based on an 8-hour working day.
Of the freelancers in Germany who have used EU MDR in their recent projects, 90% hold at least a Bachelor's degree, 48% hold at least a Master's degree, and 15% hold a doctorate.
On average, freelancers in Germany who have used EU MDR in their recent projects have 23 years of professional experience, with a single engagement typically lasting around 3.3 years.
The most common languages among freelancers in Germany who have used EU MDR in their recent projects are German (100%), English (100%), and French (17%).
The most common industries among freelancers in Germany who have used EU MDR in their recent projects are Healthcare (96%), Manufacturing (72%), and Information Technology (45%).
The most common business areas among freelancers in Germany who have used EU MDR in their recent projects are Quality Assurance (96%), Product Development (83%), and Project Management (77%).
Main locations of FRATCH Experts, who have recently used EU MDR
Our freelancers and interim experts are at home across the DACH region — available on-site in the major business hubs or fully remote. Choose a location to discover matched specialists, local market insights and up-to-date availability.
Countries:
- Germany
- Switzerland
Berlin Hamburg Munich Cologne Frankfurt Stuttgart Dusseldorf Leipzig Dortmund Essen Bremen Dresden Hanover Nuremberg Request a free demo
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FRATCH CEO
