ISO 13485 Experts
matched in minutes from over 15,000 CVs with vetted, available specialistsHire experts who know medical device quality systems, design controls, risk management, supplier oversight, and audit-ready documentation under ISO 13485:2016. Get fast, precise matching with vetted, available freelancers.
Meet FRATCH Experts who have recently used ISO 13485
Stephan Johne
Last position:
Technical Writer at pro-beam
Technical writer at a special-purpose machine manufacturer for implementing the requirements of the EU-MVO into technical documentation and FMEA moderation. Role: Technical writer and FMEA moderator
Jessica Diederen
Last position:
Consultant at Jessica Diederen Consulting
- Workflow automation
- Process management
- Scrum Master
- Introduction of new office processes on a regional and global level
- Project support in ISO 9001, 13485, and 17025 projects
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.
Andreas Seidl
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
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.
Stephan Fritsch
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.
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
Rüdiger Schüller
Last position:
Interim Manager / Self-employed Engineer at E.M.S - Engineering & Management Service GmbH
- C-level support, director, senior management and R&D/BU lead roles
- Strategic and operational corporate management and development
- Strategic and technical product and total system development
- Overall project and multi-project management
- Medtech, automotive, plant and special machinery construction, hydrogen/fuel cell
- Project planning and implementation of alternative energy solutions (PV, wind, hydro) including energy storage and trading
- Consulting and implementation of alternative drive solutions
- Development and project coordination from idea to implementation
- Leading and coordinating interdisciplinary and international teams and BU interface communication
- Customer support and development of customer-specific solutions
- Sizing, development and selection of required components
- Development, planning and assembly of solutions in special machinery and alternative energy and drive technology
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
91%
Master's degree or higher
59%
Doctorate
20%
Certifications per freelancer
5
Most common languages
German, English, French
Speak two or more languages
98%
Based on our profile pool as of 6 Sep 2026.
Daily rate distribution
The chart shows how the daily rates of freelancers in this technology 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 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 6 Sep 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
About the technology
Quality systems
ISO 13485 is the quality management standard used in the medical device industry. It helps companies define controlled processes for design, production, servicing, and supporting documentation. Strong specialists turn the standard into working procedures, records, and clear responsibilities.
Where it fits
- Medical device design and development
- Manufacturing and assembly controls
- Supplier and contract manufacturer oversight
- Complaint, corrective action, and traceability processes
- Internal audit and management review support
What specialists deliver
Companies bring in ISO 13485 experts when they need a quality system built, repaired, or prepared for an audit. Common work includes gap assessments, procedure writing, record templates, training, and help aligning teams across engineering, quality, and operations. The best professionals keep the system practical, not just compliant.
Skills that matter
A strong ISO 13485 specialist understands risk-based thinking, document control, design control, nonconformance handling, CAPA, and supplier qualification. They also know how to map requirements into usable workflows and evidence. Familiarity with related standards such as ISO 14971 and FDA quality system expectations is often valuable.
Signs you need help
- Your procedures exist but do not match real practice
- Audit findings keep repeating in the same areas
- Product files are inconsistent or hard to trace
- You are launching a new device or site
- You need temporary support for a quality project
Working model
ISO 13485 work often starts remotely, because documentation, process mapping, and gap reviews can be done from anywhere. On-site time is useful for plant walkthroughs, team training, and observing how records are actually created. Clear communication matters, especially when multiple teams must align on one quality system.
Frequently asked questions
Key details about ISO 13485, drawn from the questions we get asked most.
ISO 13485 defines how a medical device quality management system should work. It covers documentation, control of processes, supplier management, corrective action, and records that show the system is maintained. It is built for organizations that design, make, service, or distribute medical devices and related components.
ISO 13485 is more focused on medical devices and the controls needed for safety, traceability, and regulatory evidence. ISO 9001 is broader and centers on general quality management across many industries. Companies often use ISO 13485 when they need a system aligned to medical device expectations, not just general quality goals.
A company usually brings in a ISO 13485 specialist when it is building a new quality system, preparing for an audit, or fixing gaps after findings. It also helps when product documentation, supplier control, or CAPA handling has become inconsistent. Short-term support is common when internal teams are busy or need a fresh review.
A strong ISO 13485 expert usually brings related knowledge in risk management, document control, internal auditing, and supplier oversight. Familiarity with ISO 14971, design controls, and medical device regulatory workflows is often important. The best specialists can connect the standard to daily operations instead of treating it as paperwork.
That depends on the scope, but ISO 13485 work usually needs more than a general quality background. Small gap reviews may fit a focused specialist, while full system design or remediation needs someone who has worked through audits and cross-functional process changes. The key is proven medical device quality work, not just familiarity with the standard.
Much of the ISO 13485 work can be done remotely, especially document review, process mapping, and procedure writing. On-site time becomes useful when the specialist needs to see how manufacturing, labeling, or record handling works in practice. Many projects use a mix of both, depending on how mature the system is.
Look for a ISO 13485 specialist who can explain requirements in plain language and show how they apply to your actual processes. Good signs include clean documentation, practical gap assessments, and recommendations that your team can really implement. They should also understand how to prepare evidence for audit without overcomplicating the system.
No. ISO 13485 is used by manufacturers, but also by companies involved in design, servicing, distribution, and outsourced activities. If a business touches the medical device lifecycle and needs controlled processes, the standard can matter. That is why the right specialist often looks beyond the shop floor and into the full supply chain.
The average hourly rate of freelancers who have used ISO 13485 in their recent projects is 115 €, which corresponds to a daily rate of about 921 € based on an 8-hour working day.
Of the freelancers who have used ISO 13485 in their recent projects, 91% hold at least a Bachelor's degree, 59% hold at least a Master's degree, and 20% hold a doctorate.
On average, freelancers 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 who have used ISO 13485 in their recent projects are German (99%), English (95%), and French (21%).
The most common industries among freelancers who have used ISO 13485 in their recent projects are Healthcare (78%), Manufacturing (77%), and Automotive (48%).
The most common business areas among freelancers who have used ISO 13485 in their recent projects are Quality Assurance (93%), Project Management (82%), 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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