EU MDR Experts
for compliant medical device launches, matched in minutes with vetted and available freelancersHire experts who guide classification, technical documentation, clinical evaluation and post-market surveillance under EU MDR. FRATCH matches you quickly and precisely with vetted, available freelancers who fit your regulatory project.
Meet FRATCH Experts who have recently used EU MDR
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, with a focus on workflow digitization and PLM
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 an automotive test bench platform at Automotive supplier
In this project, I was responsible for designing and implementing 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 UML modeling used consistently throughout. This structured approach significantly increased the reusability of individual LabVIEW test modules and sustainably reduced development time for subsequent projects. I also integrated modern automotive standards such as CAN FD, LIN, and safety requirements, making the solution future-proof.
Technologies: LabVIEW, Visio, UML, CAN FD, LIN, DMM, Safety, Image processing, Project management, HMI, C#, C++, Python, Rust, CI
Roland S.
Last position:
Aerosol Generator Technology – Industrialization Partnerships
Aerosol Generator Technology – Industrialization Partnerships
Engaged by a former technology partner to identify and approach potential partners for further industrialization and commercialization of its vibrating membrane nebulizer aerosol generator technology.
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.
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.
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
Oliver B.
Last position:
Managing Partner / Senior Consultant / Senior Project Lead at BCOB GmbH
Project leadership for more than 150 validation and verification projects for medical ceramic implants (hip, knee, shoulder, spine and dental) in production areas with presses, mills, turning, grinding, milling, polishing, proof, laser, washing and packaging equipment as well as cleanrooms at international locations
Management of the Validation Team and overall planning of validation activities, including preparation of application specifications, equivalence analyses, risk classifications and validation plans (VP/DP/IP/OP/PP/FAT)
Execution of FATs at suppliers, preparation of FAT and Final Reports for regulatory submissions to authorities and customers
Participation in internal, authority and customer audits
Senior project leadership for SAP PS-BAU at a leading bank in Frankfurt: management of the development team, coordination of external service providers, Single Point of Contact for the business unit, support during the concept phase and test management
Consulting and delivery of training and workshops on quality, validation and regulatory requirements for international equipment manufacturers and system integrators
Consulting and project leadership in supply chain, logistics and procurement for international customers
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)
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
3.2 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
50%
Doctorate
17%
Certifications per freelancer
6
Most common languages
German, English, French
Speak two or more languages
100%
Based on our profile pool as of 16 Oct 2026.
Daily rate distribution
The chart shows how the daily rates of experts in this technology are distributed, based on recent contracts on our platform. Each bar covers a rate range — its height shows the share of experts charging 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 16 Oct 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 (71%)
- Information Technology (47%)
- Pharmaceutical (43%)
- Professional Services (41%)
- Automotive (39%)
- Energy (33%)
- Biotechnology (31%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
Regulatory scope
EU MDR, formally the European Union Medical Device Regulation, governs how medical devices are classified, assessed and placed on the European market. It covers manufacturers, authorised representatives, importers and distributors, with requirements spanning safety, performance, documentation, traceability and post-market obligations.
Classification work
Classification determines the conformity assessment route, evidence requirements and role of a notified body. Strong specialists assess intended purpose, duration of use, invasiveness, active functions and risk. They document the rationale and connect it to applicable standards and procedures.
Technical files
EU MDR projects often involve technical documentation, the clinical evaluation report, risk management and post-market surveillance plans. Professionals work with ISO 13485 quality systems, ISO 14971 risk management, usability engineering, software lifecycle controls and relevant harmonised standards. They also prepare records for audits and conformity assessment.
Device applications
Companies bring in freelance expertise when launching, updating or remediating devices across healthcare and life sciences. Typical deliverables include:
- Device classification and regulatory strategy
- Technical documentation and clinical evaluation
- Quality management system procedures
- Post-market surveillance and vigilance processes
- Notified body audit and remediation support
When support matters
External specialists are useful when an internal quality or regulatory team faces a submission deadline, a portfolio transition or an audit finding. They can review legacy evidence, close documentation gaps, coordinate cross-functional input and establish practical processes without taking ownership away from the manufacturer.
Strong specialist profile
The strongest EU MDR professionals translate regulatory text into controlled, usable work. They understand the relationship between product design, clinical evidence, risk controls, labelling, unique device identification and surveillance. Look for clear decision records, experience with notified body interactions and the ability to explain requirements to quality, medical, software and commercial teams.
Frequently asked questions
Key details about EU MDR, drawn from the questions we get asked most.
EU MDR sets the rules for placing medical devices on the European Union market and keeping them compliant after launch. It covers classification, conformity assessment, technical documentation, clinical evidence, labelling, traceability and post-market surveillance.
EU MDR is a regulation with more directly applicable and detailed requirements than the former Medical Devices Directive. It places stronger emphasis on clinical evidence, economic operator responsibilities, device identification, post-market monitoring and oversight of certain software and higher-risk products.
A capable EU MDR specialist often brings quality management, ISO 13485, ISO 14971 risk management and clinical evaluation skills. Depending on the product, experience with medical software, usability engineering, cybersecurity, labelling and notified body communication is also valuable.
The right EU MDR experience depends on device class, novelty, clinical claims, software involvement and the maturity of the quality system. A documentation review may need a focused specialist, while a new or higher-risk device benefits from someone who has led classification, evidence planning and conformity assessment.
Much of EU MDR work can be completed remotely through controlled document access, structured reviews and online meetings. On-site time may still help with manufacturing-process reviews, quality audits, laboratory coordination or workshops with product and clinical teams.
For EU MDR support, ask for examples of comparable device types, classification decisions, technical files and audit or notified body work. Also check whether the professional can separate regulatory interpretation from assumptions and leave an evidence-based, traceable record of each decision.
EU MDR can apply to software that meets the definition of a medical device or forms part of one, including software that provides medical information or influences diagnosis or treatment. Classification depends on intended purpose and risk, so software specialists should also understand clinical evaluation, cybersecurity, usability and lifecycle controls.
Professionals choose EU MDR because it combines regulatory analysis with product, clinical, quality and technical work. Freelance assignments can include portfolio remediation, submission preparation, surveillance systems and support for manufacturers entering the European market.
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, 50% hold at least a Master's degree, and 17% 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 3.2 years.
The most common languages among freelancers who have used EU MDR in their recent projects are German (100%), English (100%), and French (16%).
The most common industries among freelancers who have used EU MDR in their recent projects are Healthcare (96%), Manufacturing (71%), and Information Technology (47%).
The most common business areas among freelancers who have used EU MDR in their recent projects are Quality Assurance (96%), Product Development (82%), and Project Management (78%).
Main locations of FRATCH Experts, who have recently used EU MDR
Our freelancers and interim experts are at home all over Germany — available on-site in Berlin, Hamburg, Munich and every major business hub, or fully remote. Choose a city to discover matched specialists, local market insights and up-to-date availability.
Berlin Hamburg Munich Cologne Frankfurt Stuttgart Dusseldorf Leipzig Dortmund Essen Bremen Dresden Hanover Nuremberg In Austria our freelancers and interim experts support companies from Vienna to Graz — on-site where your project needs them, or fully remote. Choose a city to discover matched specialists, local market insights and up-to-date availability.
Vienna Graz Across Switzerland our specialists are active in Zurich, Geneva, Basel and Bern — working on-site or fully remote. Choose a city to discover matched specialists, local market insights and up-to-date availability.
Zurich Geneva Basel Bern Countries:
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FRATCH CEO
