ISO 14971 Experts
to strengthen medical device safety with fast, precise AI matchingHire experts who define risk management files, connect hazards to controls, and support regulatory evidence for medical devices and in vitro diagnostic products. FRATCH matches you quickly with vetted, available freelancers suited to your project.
Meet FRATCH Experts who have recently used ISO 14971
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
Roland S.
Last position:
Aerosol Generator Technology – Industrialization Partnerships
Aerosol Generator Technology – Industrialization Partnerships
Engaged by a former technology partner to identify and approach potential partners for further industrialization and commercialization of its vibrating membrane nebulizer aerosol generator technology.
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-...
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.
Cavit S.
Last position:
Renovation of own properties at Private building project
- Independent planning and execution of renovation projects on several residential properties, including coordination of trades, budget and schedule control, site supervision, material procurement and quality control
- Experience in interior finishing, building services, exterior areas, as well as compliance with construction and energy efficiency standards
Unnikuttan V.
Last position:
Managing Director (Co-Founder) at AathmaSignals
- Spearheading investor outreach and partnership development as founding MD, building the business case and technical narrative needed to attract initial funding and strategic collaborators in the digital health space
- Designing multi-agent AI systems for autonomous biosignal analysis, orchestrating LLM-based reasoning pipelines with domain-specific medical context to enable intelligent, clinical decision support
Peter S.
Last position:
Project Manager Camera Systems/Lenses at S&E Consulting Peter Sperber
- Management of internal and external optics, electronics, and software developers and the subproject managers throughout the entire development process up to handover to production
- Conducting RfP and contract negotiations with German, Chinese, and Japanese manufacturers and tracking the agreed deliverables
- Conducting quality gates throughout the development process
- Responsibility for meeting commercial, technical, and schedule requirements (resource and budget planning)
- Continuous monitoring of potential project risks during all phases
- Ensuring compliant development (RoHS & REACH) and documentation for worldwide CE marking
- Project status reporting to upper management and the company board
- Central point of contact for third-party contractors and their coordination in the project
Rasika D.
Last position:
Manuscript Consultant at R.D.V.V - Jbp
- Developed and managed content across diverse platforms, adapting tone, structure, and style to meet audience expectations and editorial standards
- Conducted in-depth research to ensure content accuracy, relevance, and alignment with client objectives and subject-matter requirements
- Edited and refined client manuscripts and drafts to improve clarity, narrative flow, coherence, and reader engagement
- Managed multiple concurrent content projects, prioritizing tasks and meeting tight deadlines while upholding high-quality standards
- Provided uncredited editing support for various publications, ensuring polished, consistent, and publication-ready final manuscripts
Dieter H.
Last position:
HSE Consultant (Field Core / General Electric), Stadtwerke München GUD2 Power Plant at Health & Safety Consulting Engineering Office
- Advised as HSE Consultant on behalf of Field Core / General Electric during maintenance and repair of the gas turbine at the GUD2 power plant of Stadtwerke München.
- Organized, monitored, and managed project teams from an HSE perspective.
- Implemented and oversaw the HSE plan according to the German Construction Site Ordinance (BauStellV, SiGe plan).
- Conducted induction and toolbox training on safety topics.
- Prepared and handled risk assessments and method statements (RAMS).
- Implemented and controlled LOTO procedures.
- Managed hazardous substances, including MSDS documentation.
- Oversaw the permit-to-work process.
- Took measures to prevent accidents and injuries, documenting them in the GE-Gen Suite as part of "Mission Zero".
Thomas A.
Last position:
Interim Management at Vincorion Power Systems GmbH
- Process and project management to optimize products and development processes for energy systems
- Technical risk management
- Requirements engineering and system architecture
- System FMEA of power generator units and energy storage modules aiming for generic structures
- Claims management according to Section 313 of the German Civil Code
- Regulatory environment: military and NATO standards, AQAP, VG norms
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
Elena C.
Last position:
Plant Quality Manager at BHC Gummi-Metall GmbH
- Reviewing customer requirements (Quality Agreements) and implementing process and product quality measures within the approval processes (start-up support and initial samples according to PPF/PPAP) under APQP
- Main contact for quality-related issues at the site
- Implementing supplier quality support and development
- Ensuring compliance with all quality-specific requirements such as incoming and outgoing inspections, initial sample test reports, quality work instructions, inspection plans, and control charts
- Customer contact for complaint management and handling using Quality Core Tools: 8D report, 5 Why, Ishikawa analysis
- Active use of quality tools: control plan, PFMEA, inspection plan, EMPB, drawings, collecting and analyzing statistical data, R&R, MSA, SPC
- Conducting internal system, product and process audits according to VDA 6.3 and VDA 6.5
- Responsible for certification of the quality management system IATF 16949, occupational health and safety ISO 45001, and environmental management ISO 14001
- Supervising, goal-oriented leadership and development of a 10-member team
Volker R.
Last position:
Interim Manager / Validation Project Manager at Medical Technology
- Creation of medical templates according to ISO 13485:2016 and GMP / MDR.
- Design Qualification (DQ).
- Validation plan (VP).
- Creation of PFMEA / FMEA.
- Installation Qualification (IQ).
- Operational Qualification (OQ).
- Performance Qualification (PQ).
- Final report (AB).
Jean S.
Last position:
Introduction to ISO 27001 at Software developer
- Introduction of an information security management system into an existing management system according to ISO 9001
Discover over 15,000 top freelancers
Statistics of experts using ISO 14971
Aggregated from the professional profiles of matched freelancers.
Experience
24 years
Position duration
2.1 years
Positions per freelancer
14
Top business areas
Quality Assurance, Project Management, Product Development
Top industries
Healthcare, Manufacturing, Pharmaceutical
Certification focus areas
Quality Assurance, Product Development, Project Management
Bachelor's degree or higher
90%
Master's degree or higher
50%
Doctorate
13%
Certifications per freelancer
5
Most common languages
German, English, French
Speak two or more languages
100%
Based on our profile pool as of 16 Oct 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 14971
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 16 Oct 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
ISO 14971 experts industry focus
See which industries our matched freelancers work in most often — every figure is calculated live from the freelancers on FRATCH.
- Healthcare (91%)
- Manufacturing (76%)
- Pharmaceutical (53%)
- Information Technology (50%)
- Automotive (47%)
- Biotechnology (35%)
- Professional Services (29%)
- Energy (26%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
What ISO 14971 covers
ISO 14971 is the international standard for applying risk management to medical devices. It guides manufacturers from intended-use definition and hazard identification through risk control, evaluation of residual risk, and post-production monitoring. The standard applies across the product life cycle, including software, hardware, accessories, and in vitro diagnostic devices.
Core risk processes
A compliant process links each hazard to a foreseeable sequence of events, a hazardous situation, potential harm, and documented controls. Strong specialists establish traceable criteria for risk acceptability and verify that controls work as intended. They also assess whether controls introduce new risks and maintain the risk management report as evidence.
- Define intended use and reasonably foreseeable misuse
- Identify hazards, hazardous situations, and harms
- Select and verify risk control measures
- Evaluate overall residual risk and production feedback
Ecosystem and evidence
ISO 14971 work connects with systems engineering, usability engineering, software life-cycle processes, and clinical evaluation. Professionals often work with ISO 13485 quality systems, IEC 62304 software processes, IEC 60601 safety requirements, IEC 62366 usability engineering, and design-control records. Useful outputs include hazard analyses, risk control matrices, benefit-risk assessments, traceability links, and post-market surveillance inputs.
When companies need specialists
Companies bring in freelance expertise when a new device needs a risk management process, an existing file requires remediation, or a product is moving toward a regulatory submission. External specialists can also support acquisitions, supplier changes, software updates, and audits where records must be complete and internally consistent.
- Establish a risk management plan and file structure
- Review legacy analyses for missing links or weak rationale
- Align design, verification, clinical, and quality evidence
- Prepare teams for audit questions and corrective action
What strong professionals deliver
Strong ISO 14971 professionals understand both the wording of the standard and the device itself. They ask how users interact with the product, how components can fail, and how manufacturing or maintenance can change risk. Their work is practical, traceable, proportionate to the device, and clear enough for design, quality, regulatory, and clinical teams to use together.
Choosing the right expertise
Look for experience with the device type, intended market, software content, and applicable conformity requirements. Ask to review anonymized examples of risk files, control rationales, traceability methods, and post-market updates. A capable specialist can explain trade-offs plainly, challenge unsupported assumptions, and collaborate with remote or on-site teams without losing document control.
Frequently asked questions
Everything clients usually want to know about ISO 14971, in one place.
ISO 14971 is used to manage risks associated with medical devices throughout their life cycle. It helps teams identify hazards, reduce risks through appropriate controls, evaluate residual risk, and use production and post-production information to keep the process current.
ISO 14971 focuses specifically on medical device risk management, while ISO 13485 defines broader quality management system requirements. They work together: the risk process supplies safety evidence, and the quality system governs how that process is controlled, documented, and maintained.
A strong ISO 14971 specialist often understands design controls, usability engineering, software life-cycle processes, clinical evaluation, and post-market surveillance. Familiarity with ISO 13485, IEC 62304, IEC 62366, and IEC 60601 can be important depending on the product.
The right level of ISO 14971 experience depends on device complexity, software content, market requirements, and the condition of the existing documentation. A focused file review may need a different specialist profile from building a risk process for a novel or connected device.
ISO 14971 work is often suitable for remote collaboration because risk files, design records, and review comments can be managed digitally. On-site sessions may still help when specialists need to observe production, inspect device use, or facilitate workshops with cross-functional teams.
A typical ISO 14971 engagement may produce a risk management plan, hazard analysis, risk control matrix, traceability records, residual-risk evaluation, and risk management report. The exact deliverables should match the device, development stage, and submission or audit objective.
Assess whether an ISO 14971 professional can connect hazards, harms, controls, verification evidence, and residual-risk decisions without gaps. Ask how they handle foreseeable misuse, production feedback, control failures, and situations where a risk cannot be reduced further.
Before starting an ISO 14971 project, freelancers should clarify the device scope, intended use, target markets, development stage, available evidence, and document-control process. They should also understand who owns design decisions and how risk decisions will be approved and maintained.
The average hourly rate of freelancers who have used ISO 14971 in their recent projects is 117 €, which corresponds to a daily rate of about 933 € based on an 8-hour working day.
Of the freelancers who have used ISO 14971 in their recent projects, 90% hold at least a Bachelor's degree, 50% hold at least a Master's degree, and 13% hold a doctorate.
On average, freelancers who have used ISO 14971 in their recent projects have 24 years of professional experience, with a single engagement typically lasting around 2.1 years.
The most common languages among freelancers who have used ISO 14971 in their recent projects are German (100%), English (97%), and French (21%).
The most common industries among freelancers who have used ISO 14971 in their recent projects are Healthcare (91%), Manufacturing (76%), and Pharmaceutical (53%).
The most common business areas among freelancers who have used ISO 14971 in their recent projects are Quality Assurance (97%), Project Management (88%), and Product Development (76%).
Main locations of FRATCH Experts, who have recently used ISO 14971
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.
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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