ISO 14971
ISO 14971 Consultancy & Training
The Lorit Consultancy team has extensive experience with ISO 14971 projects and is your competent partner in the field of risk management in the development of medical devices, hardware and software.
Whether you need consultancy, support or training – we support your team with our expertise in safe product design.
Why is ISO 14971 of great importance?
The development of medical devices, hardware and software is strongly linked to risk analysis and mitigation. Risks in this context refer to harm – both to patients and users – but also to damage to property or the environment.
The ISO 14971 standard specifies the process for risk management for manufacturers. The risk management process is a complex issue that requires a systematic and detailed approach from the very start and has an impact on the entire product life cycle.
ISO 14971 relation to other standards
The ISO 14971 standard is strongly linked to other standards in the field of medical technology, such as IEC 60601 (safety requirements for medical electrical equipment and in medical systems) or IEC 62304 (medical device software – software life cycle processes).
In practice, ISO TIR 24971:2020 is used as a supporting document for risk evaluation according to ISO 14971.
Our services
Consultancy & Support:
- Risk management planning
- Risk management documentation and responsibilities
- Risk evaluation and analysis
- Risk analysis techniques (FMEA, FMECA, FTA, HAZOP)
- Risk control techniques
- Risk/benefit analysis
- Post-market monitoring
- Residual risk assessment
Training:
We offer (online) training courses that can be customised to meet your requirements in terms of date, format and content.
Learn the basics of ISO 14971 with working examples, team exercises and our industry knowledge and experience. You get an overview of risk management and assessment techniques, an understanding of how to apply the standard with a detailed insight and examples of risk analysis techniques.
