ISO 14971 Expert
in minutes from over 15,000 CVs with the power of AI.Work with specialists who establish robust risk management files, conduct hazard analyses, and ensure compliance with medical device regulations. Get matched in minutes with vetted, available freelance professionals through our precise AI platform.
Meet FRATCH Experts who have recently used ISO 14971
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 Seidl
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 Voegler
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.
Volker Rank
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).
Rüdiger Schüller
Last position:
Interim Manager / Self-employed Engineer at E.M.S - Engineering & Management Service GmbH
- C-level support, director, senior management and R&D/BU lead roles
- Strategic and operational corporate management and development
- Strategic and technical product and total system development
- Overall project and multi-project management
- Medtech, automotive, plant and special machinery construction, hydrogen/fuel cell
- Project planning and implementation of alternative energy solutions (PV, wind, hydro) including energy storage and trading
- Consulting and implementation of alternative drive solutions
- Development and project coordination from idea to implementation
- Leading and coordinating interdisciplinary and international teams and BU interface communication
- Customer support and development of customer-specific solutions
- Sizing, development and selection of required components
- Development, planning and assembly of solutions in special machinery and alternative energy and drive technology
Armin Wehrle
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 SPICE™ 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 ASPICE™ 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 Sarioglu
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 Velamkudy Vijayan
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 Sperber
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 Deo
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 Hummitzsch
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 Arends
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 Weber
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
Jean Schikora
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
Elena Chis
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
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
2.3 years
Positions per freelancer
13
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 6 Sep 2026.
Daily rate distribution
The chart shows how the daily rates of freelancers in this technology 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 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 6 Sep 2026. Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
About the technology
The Standard for Medical Device Risk Management
ISO 14971 is the international standard that defines how medical device manufacturers manage risk. It establishes a systematic framework for identifying, estimating, evaluating, controlling, and monitoring hazards throughout the entire product lifecycle. Compliance with this standard is a mandatory requirement for entering global markets, including the EU and the USA.
Key Deliverables and Documentation
Specialists in this domain create the entire technical documentation required to prove safety. They translate engineering details and clinical inputs into formal risk assessments.
- Risk management plans defining the scope and criteria for acceptability
- Hazard identification and risk estimation reports
- Failure Mode and Effects Analysis documents
- Risk benefit assessments for residual risks
- Risk management reports summarizing the overall safety profile
Critical Implementation Scenarios
Companies regularly need dedicated expertise to navigate specific regulatory milestones.
- Launching new software as a medical device under MDR
- Remediating legacy technical files during transitional phases
- Preparing documentation for FDA 510k submissions
- Conducting post-market surveillance risk reviews
- Aligning internal quality management systems with updated standards
Alignment with Regulatory Ecosystems
This standard does not exist in isolation. Professionals integrate its principles with quality management systems and software lifecycle standards to build cohesive technical files. This includes mapping risks to usability engineering processes under IEC 62366 and software safety classifications under IEC 62304, ensuring that software development aligns with overall device safety profiles.
When to Onboard Freelance Experts
Bringing in external specialists is crucial when internal teams face peak workloads or lack specialized regulatory knowledge. Freelance professionals provide immediate bandwidth for major product launches or critical system audits. They bring objective viewpoints to hazard evaluations, helping companies avoid biased internal assessments and successfully pass notified body reviews.
Profile of an Accomplished Specialist
Excellent professionals combine engineering knowledge with regulatory foresight and clinical understanding. They know how to lead cross-functional risk assessment sessions with design, quality, and clinical teams. Their expertise ensures that safety controls are built into the design phase rather than added as afterthoughts, reducing rework and accelerating market clearance.
Frequently asked questions
Everything clients usually want to know about ISO 14971, in one place.
ISO 14971 is used to identify, evaluate, and control risks associated with medical devices throughout their entire lifecycle. It helps manufacturers ensure that devices are safe for patients and users before they reach the market. Implementing this framework is essential for achieving regulatory compliance with international medical device directives.
While ISO 13485 governs the overall quality management system, ISO 14971 focuses specifically on the risk management process itself. The risk management activities defined by the standard feed directly into the design, development, and post-market surveillance processes of the quality management system. Together, they form the foundation of medical device compliance.
An expert in ISO 14971 authors and maintains vital safety documentation such as risk management plans, hazard analyses, and risk management reports. They guide engineering and clinical teams through risk evaluation processes like FMEA and ensure all hazards are mitigated to acceptable levels.
Yes, software as a medical device must fully comply with ISO 14971 risk management principles. For software, specialists typically combine this standard with the IEC 62304 standard to manage risks specifically related to software lifecycle and coding anomalies.
Risk management professionals link ISO 14971 directly with the IEC 62366 usability standard. They analyze user interfaces and use environments to identify potential use errors, ensuring that all use-related hazards are controlled and documented within the final risk management file.
Look for an ISO 14971 specialist who has a proven track record of bringing similar device classes to market. They should have deep knowledge of current regulations like the EU MDR or FDA requirements, along with strong communication skills to lead cross-functional risk assessment workshops.
Yes, most risk management documentation and planning under ISO 14971 can be executed remotely. However, the expert will need remote access to technical specifications and must conduct virtual risk assessment workshops with your internal engineering and clinical teams to gather essential safety input.
Under the ISO 14971 standard, risk management is a continuous lifecycle process, not a one-time project. The risk management file must be updated regularly as new data arrives from post-market surveillance, user feedback, and clinical evaluations.
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 2.3 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 (88%), Manufacturing (76%), and Pharmaceutical (52%).
The most common business areas among freelancers who have used ISO 14971 in their recent projects are Quality Assurance (94%), 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 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:
Berlin Hamburg Munich Cologne Frankfurt Stuttgart Dusseldorf Leipzig Dortmund Essen Bremen Dresden Hanover Nuremberg Request a free demo
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