EU IVDR Experts in Germany
for compliant diagnostics, matched with vetted and available freelancers in minutesHire experts who guide in vitro diagnostic products through classification, performance evaluation, technical documentation and post-market obligations. FRATCH matches you quickly and precisely with vetted, available freelance specialists who fit your regulatory needs.
Meet FRATCH Experts in Germany, who have recently used EU IVDR
Patricia A.
Last position:
Head of Operations at StratifAI GmbH
- Designed, managed, and implemented the company’s operational, compliance, procurement, and financial strategy, ensuring alignment with rapid scaling and regulatory objectives.
- Built and scaled operational infrastructure across IT, HR, Finance, Procurement, and Compliance, supporting growth from 4 to 20 team members in 6 months.
- Oversaw financial management of OPEX, including budgeting, monitoring, and cost optimization to sustain high-growth operations.
- Developed and executed a procurement strategy, including vendor selection, negotiation, and performance oversight.
- Procured and managed external consultants (compliance, quality, regulatory experts) and orchestrated collaboration across internal teams and external partners to meet milestones.
- Implemented policies, SOPs, and business systems (compliance tracking, eQMS, payroll, vendor management, data governance) to support regulatory compliance and scalability.
- Managed and actively oversaw regulatory and compliance programs, embedding GDPR, HIPAA, SOC 2, ISO 27001, and ISO 27701 requirements into day-to-day operations.
- Directed the rollout of a Quality Management System (QMS) aligned with ISO 13485 to prepare for medical device and AI regulatory certifications.
- Led people and culture development, establishing onboarding, performance management, and cross-functional collaboration structures to scale the organization effectively.
- Established risk management and business continuity frameworks, including security controls, risk registers, and compliance safeguards.
- Engaged executive leadership, board, and investors to align operational strategy with corporate goals and market expansion.
- Enabled technology-driven operations, selecting and implementing digital systems (e.g., Drata, Qualio) to ensure compliance and efficiency.
- Scaled StratifAI’s operational backbone to support rapid growth and international market readiness.
- Achieved ISO 27001, ISO 27701, SOC 2, GDPR, and HIPAA compliance within 6 months, enabling enterprise and healthcare partnerships.
- Implemented a QMS system aligned with ISO 13485, paving the way for regulatory approvals and positioning for upcoming ISO 13485 certification, CE-IVDR marking, and FDA clearance within 12 months.
- Designed and executed governance, procurement, and financial controls, ensuring efficient resource allocation and sustainable compliance.
- Established a culture of structured growth, integrating people, processes, and compliance frameworks to maintain operational excellence.
- Enabled StratifAI to confidently enter regulated US and EU markets, building the foundation for long-term expansion.
Reza M.
Last position:
Head of IT Operations at Centogene GmbH
- Advanced to directly report to C-level and lead the €1.5M budget with AWS, utilizing S3, EC2, and RDS services to run 21 accounts, 5 OUs, and 3 PB of data by architecting the AWS environment and monitoring KPIs.
- Led a strategic cloud migration from legacy systems to AWS, reducing data center costs by 42% annually. Designed and executed the transition plan, including refactoring and rehosting operations, ensuring system compatibility, and optimizing infrastructure connectivity.
- Reduced external firewall costs by €204k per month by eliminating the external service provider and bringing the function in-house, advertising on LinkedIn, screening candidates and leading the interviews.
- Lowered mobile phone costs from €276k to €60k for 300 users on 2-year contracts by negotiating better tariffs with Vodafone, removing unnecessary services for each user and standardizing across all countries.
- Saved €45k per annum by eliminating infrastructure and external IT consultancy costs in Zug, Belgrade, Berlin and Boston by reviewing the services, conducting a risk assessment and building an in-house team.
- Increased payment terms from 30 to 180 days with the four main suppliers which generated an additional €280k per month into the business by persuading them to support the company during a difficult period.
Andreas A.
Last position:
Senior Medical Director at Biogen International
- Led and supervised the development of publication content within a large neurodegenerative disease, increasing scientific impact and brand visibility.
- Collaborated with an international team and account to ensure the accuracy and effectiveness of medical communications materials.
- Oversaw the strategic planning and execution of key attendance at conferences, resulting in increased engagement with healthcare professionals.
- Contributed to Global Medical Affairs strategies, policies, and programs, and drove implementation in the international region.
- Supported the launch of new and marketed products by generating and disseminating scientific and clinical evidence, both internally and towards key external stakeholders.
- Responsible for Investigators Initiated Studies (IISs) and Non-Interventional Studies (NISs).
- Established and managed relationships with relevant KOLs, influencers, societies, associations, and prescribers, and facilitated appropriate contacts across the region.
- Developed, coordinated, and conducted external education and training for MDs, caregivers and patients, and customer support groups in line with the Medical Affairs plan.
- Provided expertise in the evaluation of complaints and adverse events.
- Worked closely with Public Affairs to align scientific and medical society support for patient advocacy initiatives.
- Educated the internal Shire community through partnering on content development and delivery of medical training, ensuring field teams have the clinical knowledge to effectively support the therapy at a local level.
- Provided medical input to marketing and product launches.
- Worked with International GBU and Therapy Advisory Board to develop the network of local country Shire MDs in the therapeutic area/business, leveraging best practices and expertise across the region, and provided medical input into product launches.
- Provided expertise on neurovascular protocol review to support global studies and programs.
- Developed medical strategies for study protocols and supported medical affairs initiatives.
- Responsible for the promotional and scientific materials review and approval.
- Led CCSM team engagements with clinical sites for therapeutic programs.
- Conducted protocol training for CCSLs in assigned Phase II/III/IV studies.
- Integrated and aligned clinician engagement strategies with therapeutic programs.
- Served as an escalation point for clinical/medical protocol issues.
- Collaborated on a multi-year global medical strategy aligned with product/R&D strategies.
- Managed safety data review, signal detection, and communication across development phases.
Monika W.
Last position:
Quality Specialist at Nexans GmbH
- Implementation of a quality management system including creating all required process descriptions and work instructions for ISO 9001:2015 certification, as well as final planning and conducting audits
- Creating action catalogs for measures needed to comply with ISO 9001 and achieve the targeted certification
- Preparing documentation related to ISO 9001
- Developing training materials for employees and managers based on the QMH and the created documentation
- Recording results of external audits of departments (incoming goods, production, warehouse logistics, procurement and supplier management, outgoing goods, shipping) according to ISO 9001
- Preparing for and participating in certification audits
Niels A.
Last position:
Consultant: Translational Sciences at Large Pharma
- Authoring biomarker planning documents, biomarker manuals, research and development reports
- Review of clinical trial and vendors’ biomarker reports
- Development of standard operating procedures and interdepartmental training materials
Juergen M.
Last position:
Freelancer at Mehring Consulting
- Senior Consultant Regulatory Affairs; Medical Devices
- Certified Lead Auditor EN ISO 13485
- Certified Information Security Officer according to ISO/IEC 27001
- Certified Lead Auditor ISO/IEC 27001
- Trainer
- Approval strategies, national and international, project management
- Classification of medical devices; all risk classes of medical devices (active and non-active), IVD devices, especially borderline products
- creating development-supporting and technical documentation for medical devices, editing existing technical documentation
- review and updating of existing quality management documentation or creating new required quality documents
- Assistance during the CE and international approval process for medical devices, including IVD medical devices
- Preparation and review of technical files; compliance with regulatory and legal requirements
- Serious Incident and Field Safety Corrective Action (Recall) reporting; correspondence with the competent authorities within the EEA
- Implementation of Quality Management System (EN ISO 13485)
- Quality Remediation
- MDR / IVDR Remediation
- Project and Risk Management
- Implementation of UDI requirements
- on-site seminar according to the individual requirements
- good relationships to notified bodies and competent authorities
Lars B.
Last position:
Owner at LifeTech Consult
- Corporate finance advisor and strategic consultant to startup companies
- Technical analyst for investors
Discover over 15,000 top freelancers
Statistics of experts using EU IVDR
Aggregated from the professional profiles of matched freelancers.
Experience
20 years
Position duration
3.3 years
Positions per freelancer
10
Top business areas
Project Management, Quality Assurance, Operations
Top industries
Healthcare, Biotechnology, Education
Certification focus areas
Quality Assurance, Information Technology, Operations
Bachelor's degree or higher
100%
Master's degree or higher
67%
Doctorate
50%
Certifications per freelancer
4
Most common languages
English, German, Spanish
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 Germany 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 Germany using EU IVDR
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.
EU IVDR 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%)
- Biotechnology (71%)
- Education (57%)
- Pharmaceutical (57%)
- Manufacturing (43%)
- Professional Services (43%)
- Energy (29%)
- Banking and Finance (29%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
Regulatory framework
EU IVDR refers to Regulation (EU) 2017/746, the European Union framework for in vitro diagnostic medical devices. It governs products that examine human specimens to provide information about health, disease, predisposition or treatment response. The regulation applies to manufacturers, authorised representatives, importers and distributors placing IVDs on the European market.
Product scope
The framework covers reagents, instruments, software, kits and systems used for diagnostic testing outside the human body. It affects products for screening, diagnosis, monitoring, prediction and companion diagnostic purposes. Intended purpose, risk class, analytical performance and clinical performance all influence the compliance route.
Compliance work
- Define intended purpose and classify the IVD under the applicable risk rules
- Build technical documentation, performance evaluation and risk management evidence
- Prepare quality management processes and conformity assessment activities
- Support CE marking, registration, vigilance and post-market performance follow-up
EU IVDR specialists connect regulatory interpretation with practical evidence planning. They help teams turn product claims, test data and quality records into a consistent compliance file.
Ecosystem and tools
Work commonly involves quality management systems, ISO 13485, ISO 14971 risk management and performance evaluation standards. Specialists may also coordinate with notified bodies, reference laboratories, clinical partners and European databases such as EUDAMED. Software documentation, cybersecurity controls, usability evidence and supplier records can be part of the same programme.
When expertise matters
- A new IVD needs classification, conformity assessment or market access planning
- An existing product requires transition, gap assessment or remediation
- A manufacturer must strengthen performance evidence or technical files
- Post-market surveillance, vigilance or notified body communication needs support
Companies in Germany often combine remote regulatory work with on-site workshops for quality, laboratory and product teams. German and English communication may both matter when documentation and stakeholders span several markets.
What strong specialists bring
Strong EU IVDR professionals read the regulation closely but also understand laboratory workflows, assay limitations and evidence quality. They distinguish analytical performance from clinical performance, challenge unsupported claims and document decisions so reviewers can follow the reasoning. Look for experience with the relevant device class, product type and conformity assessment route, plus clear collaboration with quality and technical teams.
Frequently asked questions
The facts hiring teams ask for most often when it comes to EU IVDR.
EU IVDR sets the requirements for in vitro diagnostic medical devices placed on the European Union market. It covers classification, performance evidence, technical documentation, conformity assessment, CE marking and post-market obligations.
EU IVDR replaced the former In Vitro Diagnostic Medical Devices Directive, commonly called IVDD, with a more detailed risk-based framework. It places greater emphasis on performance evaluation, clinical evidence, notified body involvement and post-market surveillance.
A strong EU IVDR specialist often combines regulatory knowledge with ISO 13485 quality systems, ISO 14971 risk management and laboratory practice. Useful adjacent skills include performance evaluation, usability, software documentation, cybersecurity, vigilance and supplier controls.
The right level of EU IVDR experience depends on the product class, intended purpose, evidence gaps and conformity assessment route. A focused gap review may need a targeted specialist, while a new or complex diagnostic product benefits from someone who has managed the full documentation and review cycle.
Much EU IVDR work can be completed remotely, including gap assessments, evidence reviews, technical documentation and procedure updates. On-site workshops in Germany can still help when teams need to align laboratory, quality and product processes or prepare for an external review.
Ask an EU IVDR professional to explain how they would classify the product, justify its intended purpose and connect analytical and clinical evidence. Quality is visible in traceable reasoning, practical documentation, clear assumptions and constructive handling of notified body or quality-system feedback.
EU IVDR can apply to software that provides information for diagnostic or therapeutic decisions when it meets the regulation's definition of an in vitro diagnostic medical device. The intended purpose, functionality, data used and role in the diagnostic process determine the regulatory assessment.
Before taking on EU IVDR work, clarify the product's intended purpose, current classification, target markets, evidence status and conformity assessment plan. Also establish access to the quality system, technical file, performance data and key stakeholders so the scope is realistic from the start.
The average hourly rate of freelancers in Germany who have used EU IVDR in their recent projects is 132 €, which corresponds to a daily rate of about 1,054 € based on an 8-hour working day.
Of the freelancers in Germany who have used EU IVDR in their recent projects, 100% hold at least a Bachelor's degree, 67% hold at least a Master's degree, and 50% hold a doctorate.
On average, freelancers in Germany who have used EU IVDR in their recent projects have 20 years of professional experience, with a single engagement typically lasting around 3.3 years.
The most common languages among freelancers in Germany who have used EU IVDR in their recent projects are English (100%), German (86%), and Spanish (29%).
The most common industries among freelancers in Germany who have used EU IVDR in their recent projects are Healthcare (100%), Biotechnology (71%), and Education (57%).
The most common business areas among freelancers in Germany who have used EU IVDR in their recent projects are Project Management (100%), Quality Assurance (71%), and Operations (57%).
Main locations of FRATCH Experts, who have recently used EU IVDR
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 Request a free demo
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FRATCH CEO
