ISO 14971 Experts
to strengthen medical device risk management with fast, precise AI matchingHire experts who establish risk management files, connect hazards to controls and support regulatory submissions for medical devices, software and connected products. FRATCH matches you quickly with vetted, available freelancers who fit your technical and regulatory needs.
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
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.
Armin W.
Last position:
Interims Head of Functional Safety & R&D Processes at SEMIKRON Danfoss GmbH & Co KG
- Planning and coordination of all safety activities and organizational development to meet the requirements of ISO 26262 and IEC 61508
- Process development according to Automotive SPICEâ„¢ and ISO 26262
- Establishment and technical leadership of the CoC Functional Safety Management and coordination and responsibility of safety activities across all projects (ASIL C and ASIL D)
- Stakeholder management and alignment with OEMs, DIA/RASIC coordination
- Steering of staff on developing functional safety and relevant work products for safety evidence
- Planning, coordination, monitoring and progress analysis of work package creation and action tracking
- Planning and execution of safety assessments and audits for internal sub-projects and external suppliers
- Creation of the safety plan and support in creating work packages for the safety case
- Conducting FMEAs, FMEDAs and FTAs
- Coordination, development and execution of safety training
- Resource and deployment planning, budget planning and controlling
- Planning, tendering, contracting and coordination of temporary external support services
- Interdisciplinary planning and coordination of activities in functional safety management according to ISO 26262
- Conducting ASPICEâ„¢ maturity assessments and deriving process improvements based on the standard requirements
- Planning, coordination and creation of the safety assurance documentation
- Central point of contact for functional safety for all organizational levels as well as NBs, OEMs and suppliers
- Reporting to the division manager
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
48%
Doctorate
10%
Certifications per freelancer
5
Most common languages
German, English, French
Speak two or more languages
100%
Based on our profile pool as of 26 Sep 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 26 Sep 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 (52%)
- Automotive (48%)
- Information Technology (48%)
- Biotechnology (33%)
- Energy (27%)
- Professional Services (27%)
Please note that freelancers can work across multiple industries, so percentages overlap.
About the technology
Purpose and scope
ISO 14971 is the international standard for applying risk management to medical devices. It covers the full product life cycle, from early concept and design through production, post-market information and retirement. The standard helps manufacturers identify hazards, estimate and evaluate risks, define controls and assess residual risk.
Risk management process
The work is built around a documented, repeatable process rather than a single assessment. Professionals define the intended use and reasonably foreseeable misuse, establish risk acceptability criteria, analyze hazardous situations and record the rationale behind decisions. They also maintain the benefit-risk analysis when risks cannot be reduced further.
Files and evidence
A strong ISO 14971 implementation produces a coherent risk management file that can be reviewed by internal teams, auditors and conformity assessment bodies. Typical deliverables include:
- Risk management plans, analyses and reports
- Hazard analyses, fault trees and risk tables
- Traceability between risks, controls, verification and residual risk
- Production and post-production monitoring procedures
Connected quality activities
ISO 14971 does not stand alone. Its controls must connect with design inputs, usability engineering, software life-cycle activities, verification and validation, clinical evaluation, complaint handling and change control. Specialists often work with ISO 13485 quality systems, IEC 62304 for medical software and IEC 62366-1 for usability engineering.
When expertise is needed
Companies bring in freelance expertise when a new device needs a risk strategy, an existing file needs remediation or a product change affects established controls. Support is also valuable before an audit, during technical documentation work or when teams need an independent review of risk acceptability and traceability.
- Set up a compliant process for a new product
- Review gaps in an established risk management file
- Integrate software, usability and cybersecurity risks
- Prepare evidence for submission or audit activities
What strong professionals bring
Experienced professionals can interpret the standard without reducing it to a checklist. They understand how device architecture, intended users, clinical context and manufacturing processes shape risk. They ask precise questions, document assumptions, challenge weak controls and keep records consistent as the product changes. Clear communication with regulatory, quality, engineering and clinical teams is essential.
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 guides hazard identification, risk estimation, control selection, residual risk evaluation and post-production monitoring.
ISO 14971 is tailored to medical devices and their clinical, regulatory and life-cycle context. A general product assessment may identify hazards, but it usually does not provide the same structure for risk management files, residual risk decisions or links to medical device evidence.
An ISO 14971 specialist should understand quality management and medical device regulations alongside risk analysis. Useful adjacent skills include ISO 13485, IEC 62304, IEC 62366-1, cybersecurity risk management, clinical evaluation and design control.
The right level of ISO 14971 experience depends on device complexity, product maturity and the condition of the existing documentation. A straightforward file review may need focused support, while a novel device or major remediation requires someone who can lead the process and defend its rationale.
Much ISO 14971 work can be completed remotely because plans, analyses, requirements and verification records are document-based. On-site collaboration can still help when the professional must observe manufacturing, inspect a device or work closely with laboratory and production teams.
A strong ISO 14971 file is internally consistent, traceable and specific to the device rather than copied from a template. Check whether intended use, hazards, controls, verification evidence, residual risks and production feedback connect clearly and support each documented decision.
ISO 14971 focuses on medical device risk management, while ISO 13485 addresses the broader quality management system. They work together: the quality system defines controlled processes, and risk management supplies product-specific decisions that influence design, production and post-market activities.
Freelancers working with ISO 14971 often review existing files, create risk analyses, define control evidence or prepare teams for audits and submissions. They need to work across quality, regulatory, software, usability and clinical topics while keeping the documentation practical and maintainable.
The average hourly rate of freelancers who have used ISO 14971 in their recent projects is 116 €, which corresponds to a daily rate of about 928 € 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, 48% hold at least a Master's degree, and 10% 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 (52%).
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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