EU MDR Experts in Germany
matched in minutes from over 15,000 CVs with the power of AIHire experts who support EU MDR documentation, technical file gaps, clinical evaluation, and post-market obligations, so your medical device team can move with clear evidence and controlled risk. Get fast, precise matching with vetted, available freelancers.
Meet FRATCH Experts in Germany, 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.
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).
Holger Beck
Last position:
Consultant for development support topics and standards at TeDiMoS GmbH
- Standards research "Product-/project-related for speed-controlled pumps".
- Support of internal development departments on standards issues nationally and internationally.
- Creation and maintenance of internal standards and test plans.
- Generation of technical requirements from normative specifications.
- Collaboration with authorities.
- Coordination with associations and organizations/authorities (VDE, UL, notified body EMC test).
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
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
Dirk Wiesner
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
Timur Güvercinci
Last position:
Senior Quality Project Expert and Consultant in the Pharmaceutical Industry at Self-Employed Consultant
- Worked with Sanofi Aventis Frankfurt/Höchst site on manufacturing of large molecules, improving QMS processes and quality optimization projects for operations
- Led a cleaning development and validation project under CFR 21/EU GMP Regulation at MSD Vet Pharma Friesoythe GmbH site for veterinary medicinal products
- Served as expert for CSV, process validation and equipment qualification system validation projects at Roche Diagnostics Deutschland GmbH Mannheim site
- Provided GMP consulting to a small IT company for development of a cloud-based documentation management system for large molecules in the pharmaceutical industry
- Provided GMP consulting to a large IT company for development of software for continued process verification of solid and liquid sterile products
Sascha Mondon
Last position:
Senior Director Lab Transformation (CEO Office) at Amedes Group
- Leading the group's transformation program task force on behalf of the CEO and representing the CEO at the sites on operational and transformation executive managerial matters
- Operational & (digital) transformation advisor to the CEO
- Operational stabilisation of the group during a group-wide Operational Excellence and Lean transformation program consisting of process improvement, digitalisation and sourcing consolidation
- Increasing efficiency through automation and AI application in close collaboration with the CIO
- Improvement of the central IT, Finance and HR departments
- Management of the OpEx Teams and advisor to the VP Operational Excellence
- Stakeholder management of shareholders, business entities and employee representatives
Discover over 15,000 top freelancers
Statistics of experts using EU MDR
Aggregated from the professional profiles of matched freelancers.
Experience
22 years
Position duration
3 years
Positions per freelancer
12
Top business areas
Quality Assurance, Project Management, Product Development
Top industries
Healthcare, Manufacturing, Information Technology
Certification focus areas
Quality Assurance, Information Technology, Product Development
Bachelor's degree or higher
87%
Master's degree or higher
46%
Doctorate
13%
Certifications per freelancer
6
Most common languages
German, English, French
Speak two or more languages
100%
Based on our profile pool as of 30 Aug 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 30 Aug 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 European Union Medical Device Regulation, also called MDR or the Medical Device Regulation. It sets the rules for placing medical devices on the EU market and keeping them compliant after launch. Companies use it to align products, evidence, labeling, and vigilance work.
Typical project work
- Gap assessments against MDR requirements
- Technical documentation and technical file updates
- Clinical evaluation and supporting evidence
- UDI, labeling, and IFU review
- PMS, PMCF, and vigilance preparation
Where experts add value
Freelance specialists help when internal teams are short on time, lack regulatory depth, or need a second pair of eyes before an audit or notified body review. They are also useful during product changes, legacy device transitions, and remediation work after a gap analysis. In Germany, this often matters for manufacturers working with local quality, regulatory, and product teams.
Ecosystem and adjacent skills
Strong professionals working with EU MDR usually understand ISO 13485, risk management, clinical evaluation, usability, and change control. They can work with quality systems, design documentation, and regulatory submission packages. They also know how to keep evidence consistent across product, labeling, and post-market records.
What strong experts do
Good EU MDR specialists write clearly, spot missing evidence early, and keep documents aligned across teams. They know the difference between compliance noise and what a notified body will actually review. They also manage timelines well, because remediation work often touches many owners at once.
When to bring in help
Bring in outside help when a device is new, legacy documentation is incomplete, or a submission has stalled. It also makes sense when your internal team needs support for a clean-up before audit, a file update after design changes, or a focused review of MDR, Medical Device Regulation, or CE-marking evidence.
Frequently asked questions
Need clarity? These are the questions we hear most often about EU MDR.
EU MDR is the rule set that governs how medical devices are placed on the EU market and how they are controlled after launch. It affects documentation, clinical evidence, labeling, vigilance, and post-market follow-up. Companies bring in specialists to turn product facts into a compliant file.
EU MDR is stricter and more detailed than the older MDD framework. It puts more weight on clinical evidence, traceability, post-market duties, and lifecycle control. That is why many teams need outside support when they move legacy products into the new rules.
A strong EU MDR specialist usually knows ISO 13485, risk management, clinical evaluation, labeling, and technical documentation. They should also understand how quality records, change control, and vigilance work together. For software or connected devices, knowledge of cybersecurity and usability is often useful too.
A good EU MDR freelancer can start with a focused document set, a product overview, and your current compliance question. The clearer the scope, the faster they can identify gaps and propose next steps. For remediation work, access to prior assessments and legacy files helps a lot.
Most EU MDR work can be done remotely, including document reviews, gap analyses, and drafting support. On-site time can help during audits, workshops, or when a team needs hands-on alignment across quality and regulatory owners. In Germany, many companies use a mix of remote work and planned visits.
Look for clear examples of technical documentation, clinical evaluation support, and post-market work, not just broad regulatory claims. A strong EU MDR specialist explains trade-offs, asks precise questions, and writes in a way that a quality team and a notified body can both follow. Consistency across files matters more than polished language.
Common EU MDR deliverables include gap assessments, remediation plans, technical file updates, clinical evaluation support, and PMS documentation. Some projects also need label and IFU checks, UDI support, or vigilance process updates. The exact mix depends on the device class and the state of the existing file.
A EU MDR freelancer will usually ask what type of device you have, what is already documented, and where the main risk sits. They also need to know whether the goal is assessment, remediation, submission support, or training. Clear access to stakeholders and files makes the work much smoother.
The average hourly rate of freelancers in Germany who have used EU MDR in their recent projects is 112 €, which corresponds to a daily rate of about 893 € based on an 8-hour working day.
Of the freelancers in Germany who have used EU MDR in their recent projects, 87% hold at least a Bachelor's degree, 46% hold at least a Master's degree, and 13% hold a doctorate.
On average, freelancers in Germany who have used EU MDR in their recent projects have 22 years of professional experience, with a single engagement typically lasting around 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 (21%).
The most common industries among freelancers in Germany who have used EU MDR in their recent projects are Healthcare (87%), Manufacturing (67%), and Information Technology (40%).
The most common business areas among freelancers in Germany who have used EU MDR in their recent projects are Quality Assurance (90%), Project Management (75%), and Product Development (71%).
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
Get in touch with the FRATCH team and we will get back to you within 4 hours.
Would you rather directly get in touch?
We always have the time for a call or email!
Philipp Thomaschewski
FRATCH CEO
