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 14971:2019 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 course that can be customised to meet your requirements in terms of date, schedule 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.

 

ISO 14971 Trainer

Dijaz Maric

Quality Management & Reliability Engineering Consultant

Gerrit Steinöcker

Functional Safety Consultant

ISO 14971 – Current dates

CourseISO 14971
Date02. Jun. / 1/2 Day
TrainerDijaz Maric
Costs€350 / £325
File
CourseISO 14971
Date06. Jul. / 1/2 Day
TrainerGerrit Steinöcker
Costs€350 / £325
File

Testimonials

”Lorit Consultancy´s support was instrumental in helping us achieve compliance in IEC-62304/ 82304 and ISO 14971 for our software-as-a-medical-device product.”
Ju Zhang – Founder, CEO Formus Labs

 

“Plexus has used the services of Lorit Consultancy in relation to a new healthcare project where insights into ISO 14971 and IEC 60601-1 international standards was needed.  We have been very impressed with the quality of knowledge within Lorit and the quality of documentation and deliverable, and we look forward to continuing to partner with Lorit in the future.”
John Simpson – Senior Manager, Engineering  Plexus

“Lorit Consultancy gave us excellent support in defining the requirements and implementing the BS EN 62304 document structure for our first product.”
Selly Saini – CEO  Inside Biometrics

“Lorit Consultancy provided a professional and efficient service in defining regulatory requirements for both new developments and legacy products.”
Alastair Mutch – VP Research and Development, Diagnostics Cardiology Spacelabs Healthcare

“Lorit Consultancy gave us great support when guiding us through the process of hardware metric generation as defined in ISO 26262.  Providing both the FMEDAs and training on the use of them.”
Geoff Owen Protean

“Very well executed, very helpful. Thank you for your time and expertise.”
Senior Electronics Engineer

 

“Essential for my job. Reduced my fear of 60601.”
Senior Mechanical Engineer

“It’s great to have the opportunity to receive this training from somebody who is obviously an expert in the topic and understands the practical implementation.”
Senior Design Assurance Engineer

 

“Excellent course and very pragmatic approach on implementing compliance.”
Senior Software Engineer

 

“The instructor was extremely engaging and clearly had excellent knowledge of the material.”
Innovation Agent