ISO 13485 Experts in Germany
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Meet FRATCH Experts in Germany, who have recently used ISO 13485
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)
Jens Matthaei
Last position:
Automation project manager at Capgemini Engineering @ ACC Battery Factory
PSA, Peugeot Citroën, France (10/2023 – 05/2024)
- Launch Manager for electrode production rolling lines
- Setup, modernization, and commissioning of cleanroom production equipment
- Management of a team of 15 Chinese technicians
- Recovery of a three-month delay and on-schedule delivery
Egor Becker
Last position:
Freelance Technical Buyer & SQM Specialist at Becker Supply Chain & Procurement (BSCP)
- Responsibility & Strategy: Global supplier qualification for an international company in the field of certified consumer goods – fully remote and handled independently.
- Core task: Supplier research and outreach (over 150 contacts in the EU, Asia, and the USA), NDA negotiations, and building a structured supplier database based on relevant product and sustainability standards.
- Key success: Built the supplier base from scratch, placed series inquiries, and independently organized and led supplier meetings – ready for serial production in a short time.
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-...
Kusay Tomeh
Last position:
Freelance System & Software Architect - DNA-Extraction Robot at QIAGEN GmbH
- System and software architecture for the QIA-symphony Connect DNA-extraction robot in Life Science / IVD automation.
- Designed features and control logic for extraction, pipetting, lysis and eluate modules using C++, PLC/ST (Beckhoff IPC / TwinCAT 3) and model-based concepts.
- Delivered ISO 13485-oriented requirements, architecture, unit/integration/regression tests and DHF/VEP/VER/TCL documentation.
- Used Polarion, Jira, Confluence, Azure and AI-assisted documentation to improve traceability and engineering efficiency.
Jozsef Ferincz
Last position:
IT project management, introduction of AI-supported software development
- Industry: software manufacturer
- Tasks: project management; tracking and coordination of projects; stakeholder management; change management; prioritization of requirements; alignment of architecture; supplier management (internal and external); release management; monitoring defect resolution with the teams; AI-supported software development, software testing and code analysis; AI prompting, prompt engineering
- Software: Jira, Confluence, MS Project, MS Teams
- Environment: IT, software development, agile, artificial intelligence (AI)
Torsten Voegler
Last position:
COO/CTO (Freelance) at Reitreal LLC
- Setting up and running operations for offering multi-level tokenized real estate investment possibilities,
- Start-up preparations, establishing a real estate investment trust (REIT)
- Communication with SEC, technology provider selection, etc.
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).
Aleksej Rovenskij
Last position:
Interim Head of Global P2P Procurement Restructuring Project / Interim Head of Procurement Department for 2 Plants at Confidential
- Led the global restructuring and efficiency improvements in operational and strategic procurement
- Restructured personnel (HR headcounts) in cooperation with works council, HR, and legal
- Outsourced partial activities (procurement and finance with invoice control) to shared service center
- Built a shared service organization
- Improved S&OP processes and digitized procurement workflows using SAP Ariba and SAP S/4HANA with e-catalogs
- Implemented SAP IBP
- Led negotiations for direct and indirect goods
- Managed 9 cross-functional workgroups
- Developed and implemented improvement proposals in coordination with corporate management
- Worked according to ISO 13485
- Achieved savings of over €7M
Stephan Fritsch
Last position:
Consultant at Toolmaking
The project covered the introduction of SAP S/4HANA including EWM. The customer makes tools for the international market, where 300 production orders and 2,000 shipments need 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 S/4HANA. My role was key user trainer and optimizing the live processes.
Kai Wolf
Last position:
Schwarz IT KG
- Migration of the software development process of a medical technology software to C/C++ package manager Conan and development of macOS-specific system components
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 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 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.
Discover over 15,000 top freelancers
Statistics of experts using ISO 13485
Aggregated from the professional profiles of matched freelancers.
Experience
24 years
Position duration
3.6 years
Positions per freelancer
13
Top business areas
Quality Assurance, Project Management, Product Development
Top industries
Healthcare, Manufacturing, Automotive
Certification focus areas
Quality Assurance, Product Development, Project Management
Bachelor's degree or higher
89%
Master's degree or higher
58%
Doctorate
21%
Certifications per freelancer
5
Most common languages
German, English, French
Speak two or more languages
97%
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 ISO 13485
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 it covers
ISO 13485 is the quality management standard for medical devices and related services. It sets the structure for controlled processes, traceability, records, and product safety across the full lifecycle. Companies use it to build compliant quality systems that support design, production, and post-market work.
Where it fits
It is common in medical device manufacturing, software for medical use, sterile products, and suppliers to regulated manufacturers. In Germany, it often sits beside local regulatory work and the needs of EU market access. Strong specialists know how ISO 13485 connects to real operations, not just policy documents.
Typical tasks
- Gap assessments against the current quality system
- SOP and process design for controlled operations
- Internal audits and management review support
- CAPA, complaint handling, and nonconformance workflows
- Supplier qualification and document control
Skills that matter
A strong specialist understands risk-based thinking, traceability, validation, training, and change control. They can write clear procedures, map evidence to requirements, and keep records consistent. They also need practical knowledge of related standards and quality tools used in regulated environments.
When to bring one in
Companies usually need freelance expertise during certification prep, remediation after audit findings, or when launching a new device or site. They also bring in specialists to tighten documentation before an assessment or to stabilize a quality system after rapid growth. Remote work is often enough, but on-site time helps with process reviews and team training.
What good looks like
Good ISO 13485 professionals work in facts, not templates. They understand how a procedure is used on the shop floor, in design control, and in supplier management. They leave behind systems that teams can keep running, with records that stand up in audits and reviews.
Frequently asked questions
Not sure where to start with ISO 13485? These answers cover the essentials.
ISO 13485 defines the quality management framework used to control medical device design, production, and related services. It helps companies keep processes consistent, document decisions, and show that safety and traceability are built into daily work. In practice, it supports certification, audits, and ongoing quality management.
ISO 13485 is focused on medical devices and the controls needed in regulated environments. ISO 9001 is broader and aims at general quality management across many industries. If you make or support medical devices, ISO 13485 usually matters more because it goes deeper on risk, validation, and documentation.
EN ISO 13485 is the European adoption of the same core standard, so searchers often use both names. In Germany, people may also refer to the medical device QMS simply as ISO 13485. A good specialist should understand the wording used in your audit, contracts, and internal documents.
A strong ISO 13485 specialist usually knows CAPA, internal audits, document control, validation, and risk management. Depending on the project, knowledge of MDR-related quality work, supplier management, and complaint handling can also matter. For software-related devices, experience with design controls and lifecycle documentation is helpful.
A ISO 13485 project can be small or complex, so the right depth depends on the gap you need to close. A focused documentation review may need a specialist with practical audit experience, while certification prep or remediation usually calls for broader quality system knowledge. Look for proven work in medical device environments, not just generic quality work.
Most ISO 13485 work can be done remotely when the task is document review, gap analysis, or procedure writing. On-site time is useful when the specialist needs to observe processes, train teams, or review how records are actually created. Many companies use a mix of both for smoother collaboration.
A reliable ISO 13485 expert can explain why each process exists, not just quote clauses. Ask for examples of audit preparation, CAPA work, supplier control, and document systems they have improved. Strong answers are specific, practical, and tied to medical device operations.
Companies often hire ISO 13485 support when they need faster progress than an internal team can manage alone. Typical reasons include audit readiness, corrective actions after findings, new product launches, and stabilizing a quality system during growth. In Germany, this often also includes support for multilingual documentation and cross-site coordination.
The average hourly rate of freelancers in Germany who have used ISO 13485 in their recent projects is 118 €, which corresponds to a daily rate of about 941 € based on an 8-hour working day.
Of the freelancers in Germany who have used ISO 13485 in their recent projects, 89% hold at least a Bachelor's degree, 58% hold at least a Master's degree, and 21% hold a doctorate.
On average, freelancers in Germany who have used ISO 13485 in their recent projects have 24 years of professional experience, with a single engagement typically lasting around 3.6 years.
The most common languages among freelancers in Germany who have used ISO 13485 in their recent projects are German (99%), English (95%), and French (22%).
The most common industries among freelancers in Germany who have used ISO 13485 in their recent projects are Healthcare (80%), Manufacturing (74%), and Automotive (45%).
The most common business areas among freelancers in Germany who have used ISO 13485 in their recent projects are Quality Assurance (93%), Project Management (81%), and Product Development (78%).
Main locations of FRATCH Experts, who have recently used ISO 13485
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.
Berlin Hamburg Munich Cologne Frankfurt Stuttgart Dusseldorf Leipzig Dortmund Essen Bremen Dresden Hanover Nuremberg 
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