ISO 13485 Experts in Austria
, matched with vetted freelancers in minutesHire experts who establish ISO 13485 quality management systems, prepare technical documentation and support audit readiness across medical device projects. FRATCH precisely matches you with vetted, available freelancers quickly.
Meet FRATCH Experts in Austria, who have recently used ISO 13485
Andreas S.
Last position:
Partner at Lemonbee
- Development of a power distribution solution for motorhomes
- Extension and adaptation of the existing prototype software for some parts of the power distribution system
- Development of missing firmware for other modules of the system
- Automation of the firmware build process through continuous integration (CI)
- Technologies used include C, Jira, Confluence, Git, GitHub, STM32, ESP32, CAN, CANopen, UART, and Zephyr
António José R.
Last position:
Quality Management Manager at cloudWerkstatt GmbH
- Set up a quality management system according to ISO 9001:2015
Elke Z.
Last position:
Business Consultant, IT Service Provider, System Coach
- Consulting and support for companies in strategic and operational changes to increase efficiency and adaptability
- Leadership coaching: Development and support of executives to strengthen decision-making, team leadership and leadership competencies
- Change management: Design and implementation of change strategies for successful introduction of new processes and structures in digital transformation projects
- Process design: Analysis, optimization and redesign of business processes, including end-to-end process management
- Planning, control and implementation of complex IT projects
- Taking on roles such as Product Owner, Scrum Master and Agile Coach
- Project management and PMO: Managing interdisciplinary teams, resource management and monitoring budgets and schedules
- Requirements engineering and business analysis
- Documentation and release management
- Taking on temporary leadership roles to stabilize and develop teams and business areas
- Employee management: Responsibility for leading and developing teams in challenging phases
- Strategic stabilization through implementation of sustainable measures
- Operational implementation of projects
Zlatko S.
Last position:
Senior Consultant at Kater Systems
- Collaborated on debugging and maintaining the existing codebase
- Created diagrams and visualizations of system architecture
- Contributed to reports and scientific documents
Honorata D.
Last position:
Lead Auditor/ Senior Product Specialist at Notified Body TÃœV SÃœD Product Service GmbH
- Valid authorization for lead Auditor for ISO 13485; MDSAP, MDR, 9001 & Taiwan
- Contracting, planning, conducting, documentation and finalizing regular, clinical and UAAs audits within the framework of the quality management systems of manufacturers of medical devices and their supply chain.
- Review of QM documents and procedures
- Review of regulatory and normative requirements
- Responsible for MedTech GCP certification Program for hospitals, laboratories and CROs according to specially developed program based on ISO 14155, ISO 20916 and GCP
- Technical Certifier authorisation for MedTech GCP
- SR-CLA (Surveillance Reviewer for clinical audit files)
- Preparation of training materials for clinical topics/audits
- Conducting internal and external training
Rene S.
Last position:
Head of Digital Services & IT at reet systems gmbh / THEOPHIL Holding GmbH
- Overall responsibility for IT, software development, and digital services of the company for brands such as Rosenberger, Rosehill, Burger King Austria (approx. 70 companies)
- Built the holding's lakehouse and data analytics platform
- Established and led the software development and IT department
- Established and led the operation (cloud-native AWS) of the B2B platform
- Connected IoT systems and developed models for predictive maintenance and production planning, data lake/lakehouse, and BI
- Preparation for ISO 27001 information security certification
- Technologies: Cloud, AWS, Java, Cypress, Angular, Python, Go
Philipp H.
Last position:
Self-employed R&D focusing on medical imaging (freelancer) at GoCompute
- Image visualization
- Image quality improvements
- Image reconstruction
- Artefact reduction
- Algorithm development, enhancement, and porting (GPU)
- C++
- CUDA
- OpenGL
- OpenCL
- VTK
- ITK
- DICOM
- Realized projects for CADS GmbH and medPhoton, a Brainlab company
Manuel K.
Last position:
Overall Project Manager for the Global Roll-Out of a Quality and Document Management System at International Medical Technology Company
- Took over overall project management after the roll-out was discontinued the previous year
- Determined the causes and planned the new approach
- Organized and conducted qualification tests for the new software versions
- Planned the project and coordinated all tasks and assignments at six locations worldwide as well as with the software supplier
- Coordinated compliance topics with the Quality Heads at the locations
- Organized and conducted Steering Committee meetings to report to management
- Successful go-live in autumn 2024
Discover over 15,000 top freelancers
Statistics of experts using ISO 13485
Aggregated from the professional profiles of matched freelancers.
Experience
21 years
Position duration
2.9 years
Positions per freelancer
11
Top business areas
Product Development, Quality Assurance, Information Technology
Top industries
Healthcare, Information Technology, Manufacturing
Certification focus areas
Information Technology, Project Management, Human Resources
Bachelor's degree or higher
100%
Master's degree or higher
88%
Doctorate
38%
Certifications per freelancer
6
Most common languages
German, English, Bosnian
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 Austria 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 Austria 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 29 Oct 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 (100%)
- Information Technology (88%)
- Manufacturing (50%)
- Professional Services (50%)
- Education (38%)
- Energy (38%)
- Automotive (25%)
- Banking and Finance (25%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
Quality standard
ISO 13485 is the international quality management standard for organizations involved in medical devices and related services. It defines controls for design, development, production, installation, servicing and quality processes. The standard emphasizes product safety, risk control, traceability and consistent regulatory compliance.
Medical device work
Companies use ISO 13485 to structure quality systems for devices, components, software and outsourced processes. It supports activities from early design controls through manufacturing release, post-market feedback and corrective action. The framework can apply to manufacturers, suppliers, contract producers and service providers.
Core documentation
Specialists work across a connected set of procedures and records rather than treating certification as a single document exercise. Common deliverables include:
- Quality manuals, procedures and process maps
- Design and development files with verification evidence
- Risk management, CAPA and change-control records
- Supplier qualification and production-control documentation
Tools and adjacent skills
Effective ISO 13485 work often connects quality management software with document control, electronic signatures, training records and audit workflows. Useful adjacent knowledge includes ISO 14971 risk management, regulatory submissions, usability engineering, validation, supplier quality and software lifecycle controls. In Austria, experts may also coordinate with teams working under European medical device requirements.
When to bring in expertise
Freelance support is valuable when a company is creating a quality system, preparing for certification or addressing findings from an internal or external audit. It can also help during a product transfer, supplier change, acquisition or remediation programme. Look for support when ownership is unclear, records are inconsistent or design controls do not reflect the current product.
Strong professionals
A strong specialist translates the standard into usable processes without adding unnecessary bureaucracy. They can trace requirements from risks to controls, evidence and approvals, and can explain decisions clearly to product, manufacturing and regulatory teams. For remote collaboration, disciplined document management and clear communication matter; on-site work may be useful for production walkthroughs, training and audit preparation.
Frequently asked questions
Quick answers to the questions that come up most around ISO 13485.
ISO 13485 is used to establish and maintain a quality management system for medical devices and related services. It helps organizations control design, production, suppliers, records, risk-related activities, complaints and corrective actions.
ISO 13485 is tailored to medical device quality and regulatory expectations, with stronger emphasis on documented processes, risk control, traceability and product safety. ISO 9001 is a broader quality standard and may not provide the device-specific structure a regulated manufacturer needs.
A capable ISO 13485 specialist often understands ISO 14971, design controls, validation, supplier quality and regulatory submissions. Experience with electronic quality management systems, technical documentation and corrective and preventive action is also valuable.
The right level of ISO 13485 experience depends on the scope, product risk and maturity of the quality system. A focused procedure review may need a narrow specialist, while a new system, remediation programme or certification preparation calls for someone who has led comparable work from planning through evidence and audit support.
ISO 13485 documentation, gap assessments and many audit-readiness tasks can be handled remotely with secure access and disciplined review workflows. On-site collaboration in Austria is more useful for production observations, process interviews, training and verification of how documented procedures work in practice.
An ISO 13485 freelancer should clarify the product scope, applicable processes, existing evidence and project risks before proposing changes. They should produce practical documents, maintain traceability and leave internal teams able to operate and update the quality system.
Assess whether the ISO 13485 specialist can connect requirements to real processes, records and risk controls rather than quoting clauses in isolation. Ask for examples of audit findings resolved, design or supplier controls implemented, and evidence that outcomes were sustained.
ISO 13485 can be relevant to software organizations, component suppliers, contract manufacturers and service providers when their activities affect medical device quality or regulatory compliance. The expected controls depend on the supplied product or service, its risks and the responsibilities defined between organizations.
The average hourly rate of freelancers in Austria who have used ISO 13485 in their recent projects is 121 €, which corresponds to a daily rate of about 967 € based on an 8-hour working day.
Of the freelancers in Austria who have used ISO 13485 in their recent projects, 100% hold at least a Bachelor's degree, 88% hold at least a Master's degree, and 38% hold a doctorate.
On average, freelancers in Austria who have used ISO 13485 in their recent projects have 21 years of professional experience, with a single engagement typically lasting around 2.9 years.
The most common languages among freelancers in Austria who have used ISO 13485 in their recent projects are German (100%), English (100%), and Bosnian (13%).
The most common industries among freelancers in Austria who have used ISO 13485 in their recent projects are Healthcare (100%), Information Technology (88%), and Manufacturing (50%).
The most common business areas among freelancers in Austria who have used ISO 13485 in their recent projects are Product Development (100%), Quality Assurance (88%), and Information Technology (75%).
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.
Countries:
- Germany
- Austria
- Switzerland
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