ISO 13485 Experts in Austria
in minutes from over 15,000 CVs with the power of AI.Hire experts who know ISO 13485 quality management systems, medical device documentation, and audit-ready processes. Get specialists for implementation, internal checks, supplier controls, and gap analysis, matched fast from vetted, available freelancers.
Meet FRATCH Experts in Austria, who have recently used ISO 13485
Manuel Kathofer
Last position:
Overall project manager for the global roll-out of a quality and document management system at International medical device company
- Took over overall project leadership after the roll-out was stopped the previous year
- Identified causes and planned a new approach
- Organized and conducted qualification tests of new software versions
- Planned and coordinated all tasks and assignments at six sites worldwide and with the software provider
- Aligned compliance topics with the quality heads at the sites
- Organized and held steering committee meetings to report to management
- Successful go-live in fall 2024
Elke Zens
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
Andreas Schuster
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
Zlatko Sehanovic
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
António José Rodrigues Fernandes
Last position:
QM Manager at cloudWerkstatt GmbH
- Setup of QM system ISO 9001:2015
Honorata Donnermair
Last position:
Lead Auditor/ Senior Product Specialist at Notified Body TÜV SÜD 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 Schakmann
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 Huber
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
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 30 Aug 2026.
Daily rate distribution
The chart shows how the daily rates of freelancers in this technology in Austria 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 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 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 sets the requirements for a quality management system in the medical device field. It is used to control design, development, production, installation, and servicing. Strong specialists turn the standard into clear procedures, records, and responsibilities.
Where it fits
- Quality management system setup and updates
- Design and development controls
- Supplier and outsourced process control
- Documented risk and traceability processes
- Internal audit and corrective action support
When to bring in help
Companies usually need outside expertise when they are preparing for certification, closing audit findings, or updating a QMS after product or process changes. This is also common when internal teams need extra capacity for documentation, training, or remediation work.
Key skills
A strong specialist understands ISO 13485, ISO 14971, and common medical device workflows. They should be comfortable with SOPs, work instructions, records, change control, and CAPA. In Austria, many projects also need clear English for cross-border teams and suppliers.
Related systems
ISO 13485 rarely stands alone. It is often used alongside regulatory files, complaint handling, supplier qualification, and design transfer documentation. Good experts know how to connect the standard with day-to-day manufacturing and product lifecycle work.
What good looks like
- Clear, usable documentation instead of paper only
- Evidence that processes are followed in practice
- Practical audit readiness, not last-minute cleanup
- Calm coordination with quality, regulatory, and production teams
- Improvements that fit the business, not just the standard
Frequently asked questions
Quick answers to the questions that come up most around ISO 13485.
ISO 13485 defines how a medical device business builds and maintains its quality management system. It helps teams control design, production, service, documentation, and corrective actions in a structured way. Companies use it to support compliance, audits, and consistent product quality.
ISO 13485 is more specific to medical devices and puts much more weight on regulatory control, traceability, and risk management. ISO 9001 is broader and fits many industries, but it does not go as deep on device-specific obligations. For medical device work, ISO 13485 is usually the better fit.
A strong ISO 13485 specialist often knows ISO 14971, CAPA, internal auditing, supplier management, and design control. Experience with document control, complaint handling, and technical file or DHF-style records is also useful. The best specialists connect the standard to real operational work.
You do not need a full internal quality team before bringing in ISO 13485 support. Outside help is useful early, especially if you are building a QMS from scratch or preparing for a certification audit. It is also valuable when you need focused remediation on one weak process area.
Much ISO 13485 work can be done remotely, especially document review, gap analysis, procedure writing, and audit preparation. On-site time helps when the specialist needs to observe production, review records with the team, or support workshops. Many projects use a mix of both.
Ask which medical device environments the ISO 13485 specialist has supported, and what they delivered: QMS setup, audit cleanup, supplier control, or certification prep. In Austria, it also helps to confirm comfort with English-language documentation and working with cross-border teams. Clear examples matter more than general claims.
Good ISO 13485 work leaves behind documents people actually use, not just files for an audit. Look for clear process ownership, traceable records, and actions that fit how the business really runs. Strong specialists explain trade-offs and keep the system practical.
A ISO 13485 freelancer can deliver a gap assessment, a full QMS documentation set, updated SOPs, training material, audit responses, or CAPA support. They may also help with supplier controls, management review preparation, and internal audit plans. The best deliverables are specific, testable, and ready for daily use.
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 968 € 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:
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