EU MDR Expert
in minutes with vetted, available freelancers matched by AIHire experts who guide medical device classification, technical documentation and conformity assessment under EU MDR, with precise matching to vetted, available freelancers who can join quickly.
Meet FRATCH Experts 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 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
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
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
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.
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 SPICEâ„¢ 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 ASPICEâ„¢ 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 26 Sep 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 26 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
Regulatory Scope
EU MDR, formally Regulation (EU) 2017/745, sets the requirements for medical devices placed on the European Union market. It covers classification, clinical evaluation, technical documentation, conformity assessment, post-market surveillance and communication with notified bodies. The rules apply across the device life cycle, from early design decisions to ongoing safety monitoring.
Classification Work
Specialists interpret the classification rules and map a device to its intended purpose, risk profile and applicable conformity route. They assess borderline products, reusable instruments, software and systems that combine hardware with digital functions. Their work helps companies define the regulatory strategy before design and evidence plans are fixed.
- Review intended purpose and device classification
- Map applicable general safety and performance requirements
- Plan clinical evaluation and performance evidence
- Identify conformity assessment and notified body needs
Documentation Systems
EU MDR work relies on consistent, traceable records. Experts create or improve technical files, design documentation, risk management records, clinical evaluation reports, labeling, instructions for use and declarations of conformity. They connect these documents so that claims, hazards, verification results and production controls support one another.
Quality And Surveillance
The regulation links product compliance to quality management and post-market processes. Freelance specialists may establish complaint handling, vigilance, trend reporting, post-market surveillance plans and periodic safety documentation. They also help integrate ISO 13485 quality practices, ISO 14971 risk management and usability engineering into operational workflows.
- Build post-market surveillance and vigilance processes
- Align risk controls with verification and validation evidence
- Prepare audit responses and corrective action plans
- Maintain change control across regulated documentation
When To Bring Expertise
Companies often seek external support when launching a new device, updating an existing portfolio or preparing for a notified body review. Specialist help is also valuable when internal teams face a classification dispute, missing clinical evidence, remediation work or a transition from older medical device rules. Remote collaboration works well for document reviews and systems design; workshops, audits and production assessments may require site access.
Strong Specialist Profile
A strong EU MDR professional combines regulatory judgment with practical knowledge of product development, quality systems and clinical evidence. They can explain a requirement in terms of design decisions, records and business risk rather than quoting rules alone. Look for clear deliverables, disciplined version control, experience with comparable device types and the ability to challenge unsupported claims constructively.
Frequently asked questions
Key details about EU MDR, drawn from the questions we get asked most.
EU MDR is the European Union framework for placing and keeping medical devices on the market. It defines requirements for classification, safety and performance, clinical evidence, technical documentation, conformity assessment and post-market surveillance.
EU MDR is more detailed and places stronger emphasis on clinical evidence, traceability, post-market surveillance and the role of economic operators. Unlike the former Medical Devices Directive, it is a regulation with more directly harmonized requirements across the European Union.
A capable EU MDR specialist often brings experience with ISO 13485 quality management, ISO 14971 risk management, clinical evaluation, usability engineering and software life-cycle controls. Knowledge of notified body interactions, labeling and vigilance is also valuable.
An EU MDR freelancer can support a new device submission, portfolio remediation, classification review, technical documentation update or post-market surveillance setup. The right level of support depends on the device class, evidence gaps, internal ownership and readiness for conformity assessment.
Much of EU MDR work can be completed remotely because classification, document review, gap analysis and regulatory planning are largely evidence-based. On-site collaboration may still be needed for production audits, quality system observations, design reviews or access to controlled records.
Ask an EU MDR specialist to explain comparable device work, their role in the conformity assessment process and the deliverables they would produce. Strong professionals connect requirements to intended purpose, risk controls, clinical evidence and clear document ownership.
EU MDR can apply to software when its intended purpose meets the definition of a medical device or when it forms part of a medical device system. Assessment depends on intended purpose, functionality, risk and the applicable classification rules, not simply on whether the product is digital.
Freelancers working with EU MDR should clarify the device scope, regulatory status, target markets, evidence available, quality system and decision authority before starting. They should also agree on document access, review gates, confidentiality and how unresolved regulatory judgments will be escalated.
The average hourly rate of freelancers 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 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 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 who have used EU MDR in their recent projects are German (100%), English (100%), and French (17%).
The most common industries among freelancers 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 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 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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