EU MDR Experts
in minutes from over 15,000 CVs with the power of AIHire experts who handle EU MDR compliance, technical documentation, clinical evaluation, PMS and UDI readiness for medical devices and software. Get fast, precise matching with vetted, available freelancers.
Meet FRATCH Experts who have recently used EU MDR
Jens-Uwe Peter
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 Eschinger
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 Fisch
Last position:
WeMatch Consulting GmbH / Contracting / Framework agreement - Novanta Medical GmbH
- Labeling BarTender
- Structure, Schema ST4 consulting.
- MDR consulting.
Andreas Seidl
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 Fritsch
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 Zakhliebaiev
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
Volker Rank
Last position:
Interim Manager / Validation Project Manager at Medical Technology
- Creation of medical templates according to ISO 13485:2016 and GMP / MDR.
- Design Qualification (DQ).
- Validation plan (VP).
- Creation of PFMEA / FMEA.
- Installation Qualification (IQ).
- Operational Qualification (OQ).
- Performance Qualification (PQ).
- Final report (AB).
Rüdiger Schüller
Last position:
Interim Manager / Self-employed Engineer at E.M.S - Engineering & Management Service GmbH
- C-level support, director, senior management and R&D/BU lead roles
- Strategic and operational corporate management and development
- Strategic and technical product and total system development
- Overall project and multi-project management
- Medtech, automotive, plant and special machinery construction, hydrogen/fuel cell
- Project planning and implementation of alternative energy solutions (PV, wind, hydro) including energy storage and trading
- Consulting and implementation of alternative drive solutions
- Development and project coordination from idea to implementation
- Leading and coordinating interdisciplinary and international teams and BU interface communication
- Customer support and development of customer-specific solutions
- Sizing, development and selection of required components
- Development, planning and assembly of solutions in special machinery and alternative energy and drive technology
Armin Wehrle
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 Döring
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 Pestsov
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 Khoury
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 Velamkudy Vijayan
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 Sperber
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
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
3.4 years
Positions per freelancer
12
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
46%
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 6 Sep 2026.
Daily rate distribution
The chart shows how the daily rates of freelancers in this technology 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 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 6 Sep 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
About the technology
What EU MDR covers
EU MDR is the EU Medical Device Regulation, also known as Regulation (EU) 2017/745. It sets the rules for placing medical devices on the EU market and keeping them compliant after launch. Strong work under EU MDR covers device classification, conformity assessment, technical files, and post-market duties.
Typical deliverables
- Technical documentation and gap assessments
- Clinical evaluation plans and reports
- PMS, PMCF, and vigilance processes
- UDI, labeling, and IFU review
- Notified Body support packages
Where specialists help
Companies bring in EU MDR specialists when a device is new, when a legacy product must be reworked, or when an audit is close. They also help software teams that build medical software, SaMD, or connected devices. The best experts turn regulation into clear tasks, evidence, and documents.
Skills that matter
Good professionals know the regulation, but they also understand risk management, clinical evidence, usability, and quality systems. They can work with QA, regulatory affairs, product, and engineering teams without slowing delivery. Familiarity with ISO 13485, ISO 14971, and software lifecycle controls is often essential.
Signs you need support
- Your documentation is incomplete or inconsistent
- Your legacy device needs an MDR transition plan
- Your clinical evidence does not match the intended purpose
- Your PMS or vigilance process is weak
- Your team needs help before a Notified Body review
How strong experts work
The best EU MDR experts are precise, methodical, and practical. They do not just quote rules; they trace each claim back to evidence and keep the file usable for future updates. They help teams make defensible decisions and reduce compliance risk without creating unnecessary process.
Frequently asked questions
Key details about EU MDR, drawn from the questions we get asked most.
EU MDR is used to prove that a medical device can be placed on the EU market and kept compliant after launch. It shapes the technical file, clinical evidence, labeling, UDI, post-market surveillance, and vigilance. Companies use it for hardware, accessories, and medical software that fall under the regulation.
Yes. EU MDR is the common shorthand for the EU Medical Device Regulation, officially Regulation (EU) 2017/745. In search and in projects, people also use “MDR” when they mean the same framework. Good specialists know how the shorthand maps to the formal regulation and its annexes.
EU MDR is stricter and more evidence-heavy than the former MDD framework. It puts more focus on clinical evaluation, post-market activities, UDI, and the full lifecycle of the device. Teams often need to rebuild older files rather than just update a few documents.
A strong EU MDR specialist usually brings risk management, clinical evaluation, labeling review, and quality system knowledge. Useful adjacent areas include ISO 13485, ISO 14971, software lifecycle controls, and work with Notified Bodies. For medical software, understanding SaMD and cybersecurity is also valuable.
EU MDR projects vary a lot. A gap assessment or document cleanup may need only focused support, while a full transition for a legacy device often needs deeper regulatory and clinical experience. The key is not the title, but whether the expert has handled devices similar to yours.
Yes, most EU MDR tasks can be done remotely because they are document-heavy and process-driven. Remote collaboration works well for technical documentation, gap analysis, clinical evidence review, and PMS process design. On-site time can help if the expert needs to inspect files, teams, or production processes directly.
Look for clear examples of work on EU MDR files, not vague claims about compliance. A good expert can explain how they handle intended purpose, risk, clinical evidence, and post-market obligations in a structured way. They should also be able to show how they work with QA, regulatory, and product teams.
Ask which device types they have supported, how they approach the technical file, and how they deal with clinical evaluation and post-market duties. For EU MDR, it also helps to ask whether they have worked with Notified Bodies and whether they understand the difference between legacy products and new submissions. The best answer is specific, practical, and tied to your product.
The average hourly rate of freelancers who have used EU MDR in their recent projects is 112 €, which corresponds to a daily rate of about 897 € based on an 8-hour working day.
Of the freelancers who have used EU MDR in their recent projects, 90% hold at least a Bachelor's degree, 46% hold at least a Master's degree, and 15% hold a doctorate.
On average, freelancers who have used EU MDR in their recent projects have 23 years of professional experience, with a single engagement typically lasting around 3.4 years.
The most common languages among freelancers who have used EU MDR in their recent projects are German (100%), English (100%), and French (19%).
The most common industries among freelancers who have used EU MDR in their recent projects are Healthcare (94%), Manufacturing (73%), and Information Technology (44%).
The most common business areas among freelancers who have used EU MDR in their recent projects are Quality Assurance (94%), Product Development (81%), 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:
Berlin Hamburg Munich Cologne Frankfurt Stuttgart Dusseldorf Leipzig Dortmund Essen Bremen Dresden Hanover Nuremberg Request a free demo
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FRATCH CEO
