ISO 13485 Experts
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Meet FRATCH Experts who have recently used ISO 13485
Aleksej R.
Last position:
Interim Senior Project Manager Global Supply Chain at Vertraulich
Company description: Toy manufacturer
Employees: 700
Revenue: 0,7 Mrd.
Global project management of Customization Hubs with 12 working groups and several production sites
Design, planning, and professional support for the establishment of regional Customization Hub and Decoupling Point structures within an international Supply Chain
Analysis of existing Supply Chain, Logistics, and product availability processes
Design and structuring of the project organization, including work packages, milestones, role models, and project dependencies
Professional support during the pilot, ramp-up, and go-live preparation phases
Documentation of project results, decisions, and implementation recommendations
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
Jessica D.
Last position:
Consultant at Jessica Diederen Consulting
- Workflow automation
- Process management
- Scrum Master
- Introduction of new office processes at regional and global level
- Project assistance in ISO 9001, 13485 and 17025 projects
Stephan J.
Last position:
Technical Writer at pro-beam
Technical writer at a special-purpose machine manufacturer, implementing the requirements of the EU Machinery Regulation in the technical documentation and moderating FMEAs. Role: Technical Writer and FMEA Moderator
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)
Jens M.
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 B.
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 T.
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 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
Torsten V.
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 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.
Frank T.
Last position:
Engineering & Industry 4.0 / IoT Project Manager at Contech Software & Engineering GmbH
Engineering & Industry 4.0 / IoT projects with an AI system based on the Robust Design method for products & processes
Development, implementation & introduction of the AI system Analyser® for Robust Design for products & processes
AI and Industry 4.0 standard product for preventive and reactive quality and safeguarding as well as maintenance (Predictive Quality and Predictive Maintenance) based on Big & Smart Data
Kai W.
Last position:
biobedded systems GmbH
- Embedded software development for EMS safety boards in medical technology according to IEC 62304 / ISO 13485
- Technologies: C++, OpenCV, Python, Qt6, JTAG, UART, CMake, IEC 62304, ISO 13485
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
3.5 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
19%
Certifications per freelancer
6
Most common languages
German, English, French
Speak two or more languages
98%
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 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 26 Sep 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
ISO 13485 experts industry focus
See which industries our matched freelancers work in most often — every figure is calculated live from the freelancers on FRATCH.
- Healthcare (80%)
- Manufacturing (77%)
- Automotive (47%)
- Information Technology (47%)
- Professional Services (39%)
- Pharmaceutical (34%)
- Energy (30%)
- Biotechnology (28%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
What ISO 13485 covers
ISO 13485 is the international quality management standard for organizations involved in medical devices. It defines controlled processes for design, development, production, storage, installation, servicing, and related support. The standard focuses on product safety, consistent documentation, risk control, and compliance across the device lifecycle.
Where it is used
Companies use ISO 13485 to build and maintain quality systems for devices, components, software, and services that support healthcare products. It applies to manufacturers, suppliers, contract producers, and organizations providing sterilization, calibration, logistics, or service activities. Typical work includes:
- Establishing quality systems for new or existing medical device operations
- Preparing design history, device master, and technical documentation
- Managing supplier qualification, production controls, and traceability
- Supporting audits, corrective actions, and regulatory submissions
Ecosystem and skills
ISO 13485 work connects quality management with ISO 14971 risk management, usability engineering, sterilization, validation, and regulatory affairs. Strong specialists understand document control, change management, nonconformity handling, CAPA, internal audits, and management review. They may also work with electronic quality management systems and production records that preserve an auditable history.
When companies need support
Freelance expertise is useful when a company is creating its first quality system, preparing for certification, entering a new market, or remediating audit findings. It can also help during product transfers, supplier changes, acquisitions, and the scale-up from prototype work to controlled production. External specialists bring focused capacity without disrupting the permanent quality team.
Signs of strong expertise
A capable professional translates ISO 13485 requirements into practical procedures that teams can follow and evidence. They distinguish a documented process from an effective one and connect quality records to real product and patient risks. Useful signs include:
- Experience with the relevant device classification and production model
- Clear ownership of CAPA, risk files, complaints, and change records
- Audit preparation based on objective evidence rather than templates alone
- Careful coordination with design, manufacturing, suppliers, and regulatory teams
Choosing the right specialist
Start by defining the product scope, lifecycle stage, markets, certification status, and immediate quality risks. Ask candidates to describe comparable systems, audit situations, deliverables, and how they work with internal teams. The best fit can explain ISO 13485 in plain language, adapt controls to the organization, and leave behind maintainable processes, complete records, and a clear path to ongoing compliance.
Frequently asked questions
Key details about ISO 13485, drawn from the questions we get asked most.
ISO 13485 is used to establish a quality management system for organizations that design, manufacture, supply, install, or service medical devices. It helps control processes, records, risks, suppliers, complaints, and corrective actions throughout the product lifecycle.
ISO 13485 is tailored to medical device quality and places stronger emphasis on regulatory requirements, risk management, traceability, validation, and documented production controls. ISO 9001 is a broader quality standard and does not by itself address the specific expectations of medical device markets.
A strong ISO 13485 specialist often brings knowledge of ISO 14971, regulatory submissions, design controls, usability engineering, supplier quality, and process validation. Experience with CAPA, complaint handling, electronic quality systems, and internal audits is also valuable.
The right level for ISO 13485 depends on the scope and stage of the work. A documentation update may need focused process knowledge, while building a complete quality system or preparing for certification calls for experience across audits, risk management, design controls, and operations.
ISO 13485 work can often be completed remotely when records, workflows, and stakeholders are accessible online. On-site time may still be useful for observing production, reviewing controlled areas, interviewing teams, or verifying that procedures match actual practices.
For ISO 13485, deliverables may include quality manuals, procedures, forms, process maps, audit plans, CAPA records, supplier controls, training materials, and remediation plans. Each document should have clear ownership, approval, revision history, and links to applicable risks or requirements.
Ask an ISO 13485 professional to explain how they handled a comparable device, audit finding, or process failure. Look for specific evidence of practical implementation, not only certification vocabulary, and check whether they can connect procedures with records, responsibilities, and measurable control.
An effective ISO 13485 system reflects how the organization actually designs, makes, tests, releases, and supports its products. It assigns responsibilities clearly, keeps records reliable, manages change and suppliers, and uses complaints, audits, and nonconformities to drive sustained improvement.
The average hourly rate of freelancers who have used ISO 13485 in their recent projects is 116 €, which corresponds to a daily rate of about 930 € 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 19% 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 3.5 years.
The most common languages among freelancers who have used ISO 13485 in their recent projects are German (99%), English (95%), and French (20%).
The most common industries among freelancers who have used ISO 13485 in their recent projects are Healthcare (80%), Manufacturing (77%), and Automotive (47%).
The most common business areas among freelancers who have used ISO 13485 in their recent projects are Quality Assurance (94%), Project Management (81%), and Product Development (77%).
Main locations of FRATCH Experts, who have recently used ISO 13485
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.
Munich 
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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