EU MDR Experts in Germany
with precise AI matching and vetted, available freelancersHire experts who guide technical documentation, clinical evaluation, risk management and conformity assessment under EU MDR. Work with vetted, available freelancers matched quickly to your product, quality system and delivery needs.
Meet FRATCH Experts in Germany, 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-...
Volker R.
Last position:
Interim Manager / Validation Project Manager at Medical Technology
- Preparation of medical templates according to ISO 13485:2016 and GMP / MDR.
- Design Qualification (DQ).
- Validation Plan (VP).
- Preparation of PFMEA / FMEA.
- Installation Qualification (IQ).
- Operational Qualification (OQ).
- Performance Qualification (PQ).
- Final Report (AB).
Kurt F.
Last position:
WeMatch Consulting GmbH / Contracting / Framework agreement - Novanta Medical GmbH
- Labeling BarTender
- Structure, Schema ST4 consulting.
- MDR consulting.
Jean S.
Last position:
Introduction to ISO 27001 at Software Developer
- Introduction of an information security system into an existing management system according to ISO 9001
Kevin P.
Last position:
Industry Software from Route to Invoice
Industry Software from Route to Invoice
In Production
In use at: landscaping company, two home care services
The entire workday, digital: sign-in, route plan on the vehicle, departure checks, photo documentation, time tracking, invoicing. The tablets keep working offline and sync afterward. Records are immutable, making time tracking easier to audit. Runs on a dedicated server in Germany with continuous monitoring and remote updates.
Proof: In daily use at the landscaping company with six vehicles since September 7, 2026.
- React Native on Android tablets
- Python
- SQLite
- Two-way synchronization
- Linux server in Germany
- Remote maintenance
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
Holger B.
Last position:
Consultant for development-related topics and standards at TeDiMoS GmbH
- Standards research "product- / project-related for speed-controlled pumps".
- Supporting internal development departments with standards-related questions nationally and internationally.
- Creating and maintaining internal standards and test plans.
- Deriving technical requirements from normative specifications.
- Cooperation with authorities.
- Coordination with associations and organizations/authorities (VDE, UL, notified Body EMC-Test).
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.
Peter G.
Last position:
Interim Program Manager at Self-employed
- Automotive program management: production readiness
- MDR implementation for medium-sized companies
- Six Sigma and Lean consulting and training for start-ups and small businesses
- Exploring cybersecurity, AI, GSPR, and clinical trials in the medical device industry
- Creating LinkedIn content (project management newsletter)
- Exploring data mining, deep learning, and artificial intelligence
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
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
91%
Master's degree or higher
51%
Doctorate
16%
Certifications per freelancer
6
Most common languages
German, English, French
Speak two or more languages
100%
Based on our profile pool as of 29 Oct 2026.
Daily rate distribution
The chart shows how the daily rates of experts in this technology in Germany 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 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 29 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 (70%)
- Information Technology (48%)
- Pharmaceutical (42%)
- Automotive (40%)
- Professional Services (40%)
- Energy (34%)
- Biotechnology (30%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
Regulatory foundation
EU MDR is the common name for Regulation (EU) 2017/745 on medical devices. It sets requirements for placing medical devices, accessories and certain software on the European market. The framework covers classification, safety, performance, clinical evidence, post-market surveillance and economic operator responsibilities.
Product scope
EU MDR work starts by defining the intended purpose and device status. Specialists assess whether a product is a medical device, determine its risk class and map the applicable conformity route. Their work can cover reusable instruments, active devices, implantable products, diagnostic accessories and software with a medical purpose.
Documentation and evidence
Strong technical files connect design decisions with objective evidence. Experts prepare or review the device description, essential requirements mapping, risk management file, usability evidence, verification records and clinical evaluation. They also align labeling, instructions for use, unique device identification and post-market documentation with the product lifecycle.
Quality system integration
EU MDR obligations sit alongside ISO 13485 quality management, ISO 14971 risk management and software standards such as IEC 62304 where relevant. Freelance specialists often coordinate quality, regulatory, clinical, software and manufacturing stakeholders. In Germany, they may also support communication with local teams, notified bodies and competent authorities in German or English.
When companies need support
Companies bring in external expertise when a product launch, portfolio review or remediation program needs focused regulatory capacity.
- Classify a new device or software product
- Close gaps in technical documentation
- Prepare for notified body assessment
- Build clinical evaluation and post-market plans
- Transfer legacy MDD or AIMDD documentation to EU MDR
What strong specialists deliver
The best professionals translate regulatory requirements into clear, traceable actions. They understand how intended purpose affects classification, evidence and claims, and they can challenge weak assumptions without slowing the project. Look for a specialist who explains decisions, maintains version control, documents interfaces between teams and leaves behind a practical compliance process rather than isolated documents.
Frequently asked questions
Need clarity? These are the questions we hear most often about EU MDR.
EU MDR establishes the rules for medical devices and related products placed on the European Union market. It governs classification, conformity assessment, clinical evidence, technical documentation, labeling and post-market surveillance.
EU MDR has broader product coverage and places stronger emphasis on clinical evidence, post-market surveillance, traceability and lifecycle controls than the former Medical Device Directive. A specialist should assess legacy documentation rather than assume that an MDD file can be reused unchanged.
A capable EU MDR specialist usually understands ISO 13485 quality systems, ISO 14971 risk management and clinical evaluation. Depending on the product, useful adjacent knowledge includes IEC 62304, IEC 62366, usability engineering, cybersecurity, software validation and notified body submissions.
The right level for EU MDR depends on the device class, product novelty, clinical evidence and condition of the existing quality system. A portfolio classification review may need focused regulatory input, while a new implantable device or complex medical software requires deeper cross-functional experience.
EU MDR activities such as document review, gap assessment and evidence planning often work well remotely. On-site sessions can still help with manufacturing reviews, design workshops and quality system implementation; teams in Germany should agree early on language, time zones and access to controlled records.
Good EU MDR work is traceable from intended purpose and claims through classification, risks, evidence and post-market controls. Ask for clear rationale, documented assumptions, useful gap priorities and experience handling comments from a notified body.
Before accepting an EU MDR assignment, clarify the device scope, target markets, current classification, quality system status and available records. Also confirm decision authority, document ownership, review gates and whether the work concerns a new product, remediation or transition from MDD.
EU MDR can apply to software when its intended purpose meets the definition of a medical device, including software that supports diagnosis, monitoring, prediction or treatment decisions. Classification depends on the software function and clinical role, so the intended purpose, claims, risk management and clinical evidence must be assessed together.
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 892 € based on an 8-hour working day.
Of the freelancers in Germany who have used EU MDR in their recent projects, 91% hold at least a Bachelor's degree, 51% hold at least a Master's degree, and 16% 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 3.2 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 (16%).
The most common industries among freelancers in Germany who have used EU MDR in their recent projects are Healthcare (96%), Manufacturing (70%), and Information Technology (48%).
The most common business areas among freelancers in Germany who have used EU MDR in their recent projects are Quality Assurance (94%), Product Development (82%), and Project Management (76%).
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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