ISO 13485 Experts in Austria
with precise AI matching and vetted, available freelancersHire experts who establish quality management systems, prepare audit evidence and connect ISO 13485 controls with risk management and regulatory submissions. FRATCH matches you quickly with precise, vetted and available freelancers for medical device quality work.
Meet FRATCH Experts in Austria, who have recently used ISO 13485
Manuel K.
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 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
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
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
António José R.
Last position:
QM Manager at cloudWerkstatt GmbH
- Setup of QM system ISO 9001:2015
Honorata D.
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 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
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 19 Sep 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 19 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 (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
What ISO 13485 Covers
ISO 13485 is the international quality management standard for organizations involved in medical devices and related services. It defines controlled processes for design, production, storage, installation, servicing and post-market activities. The standard emphasizes documented evidence, product safety, regulatory alignment and consistent risk-based decision-making.
Where It Is Used
Companies use ISO 13485 when they develop or supply medical devices, software with a medical purpose, components, sterile products or contract manufacturing services. Typical work includes:
- Establishing quality systems for new medical device operations
- Supporting design transfer, validation and production controls
- Preparing technical documentation and audit-ready records
- Managing suppliers, complaints, nonconformities and corrective actions
Standards And Tools
ISO 13485 work connects quality processes with ISO 14971 risk management, regulatory submissions, usability activities and software lifecycle controls where relevant. Specialists often work with electronic quality management systems, document control, training records, CAPA workflows, change control and audit management tools. The right toolset depends on the device, market and existing processes.
When Companies Bring In Experts
External expertise is useful during certification preparation, remediation, product launches, acquisitions and major process changes. Companies also bring in professionals when internal teams need an independent gap assessment or temporary support for an audit. In Austria, collaboration may involve local manufacturing, research or medical technology teams alongside remote stakeholders across Europe.
- A quality system has grown without consistent ownership
- Audit findings require structured corrective action
- Design and production records do not connect clearly
- Supplier controls or post-market processes need strengthening
Skills That Matter
Strong professionals understand how clauses translate into practical procedures, records and responsibilities. They can interview process owners, map workflows, identify objective evidence and write controls that teams can actually follow. Useful adjacent knowledge includes regulatory affairs, clinical evaluation, validation, software quality, supplier management and internal auditing.
Choosing The Right Specialist
Look for evidence of comparable medical device environments, not just familiarity with the standard’s wording. Ask how the professional handled audit findings, risk files, design changes, CAPA effectiveness and supplier issues. For remote work, define document access, review routines, confidentiality and language expectations early; on-site presence can help when processes must be observed on the production floor.
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 covers controlled processes such as design, production, supplier management, complaints, corrective actions and post-market activities.
ISO 13485 is tailored to medical device quality and regulatory requirements, while ISO 9001 is a broader quality management standard for many industries. ISO 13485 places stronger emphasis on documented product controls, risk, traceability and evidence that supports safety and compliance.
A strong ISO 13485 specialist often understands ISO 14971 risk management, regulatory affairs, design controls, validation and supplier quality. Experience with electronic quality management systems, CAPA, change control and audit preparation is also valuable.
The required depth depends on the device class, business model, markets and condition of the existing quality system. A focused gap review may need a narrower specialist profile, while certification preparation, remediation or a new system calls for broader hands-on experience across several processes.
ISO 13485 work can often be performed remotely when documents, process owners and quality records are accessible online. On-site collaboration in Austria is useful for observing production, warehouse or laboratory activities and for interviewing teams directly; German or English requirements should be agreed at the start.
Companies commonly seek an ISO 13485 freelancer before certification, after audit findings, during a product launch or when internal quality resources are limited. A specialist can provide an independent gap assessment, create controlled procedures, support implementation and prepare teams for auditor questions.
Ask for clear examples of quality systems, audit findings and corrective actions the professional has handled in comparable medical device settings. Good work links each requirement to an owner, process, record and objective evidence, rather than producing generic documents that teams do not use.
Typical ISO 13485 deliverables include a gap assessment, quality manual, process maps, procedures, forms, audit plans, supplier controls and CAPA records. Depending on the project, the specialist may also support risk management files, training, management review and certification audit responses.
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:
- Germany
- Austria
- Switzerland
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