The development of medical devices is driven by risk identification and mitigation.

Let´s take a defibrillator as an example. To ensure that this device fulfils the safety requirements defined in standards such as IEC 60601 and its particular standard 60601-2-4 is a major challenge. Through the whole development process, it is key to identify potential risks in the device, in systems, hardware and software to be successful in the market and at the end of the day to save lives.

 

For that reason and because compliance is a requirement for most markets every company needs experienced engineers who know how to implement, maintain and work with the IEC 60601 series of standards.

 

Our experience

The Lorit Consultancy Team has many years of experience in software and hardware development in various industries. Since 2014 we are working as consultants and trainers on functional safety related projects. With our broad experience in risk management and regulatory compliance, we assist you in ensuring that your medical devices fulfil the safety requirements defined in IEC 60601-1 and many other standards.

    

 

 

Advanced course for enhancing your risk management

Our aim is to support our clients to get a clear understanding of the safety standards in the medical device sector and enable them to successfully comply with regulatory approvals. We recently set up an additional course for the medical device industry. Beside our existing IEC 60601-1 Introductory course we are now offering an IEC 60601-1 Advanced course.

 

The course focuses on:

  • System, hardware and software architecture
  • Expanding the concepts of Programmable Medical Electrical Systems (PEMS) section 14
  • Many practical examples of essential performance, risk control and basic safety for a variety of products
  • Quantitative risk analysis
  • Inductive and deductive risk management techniques such as Fault Tree Analysis (FTA) and Failure Mode and Effects Criticality Analysis (FMECA)
  • Considerations for safety critical products and the relationship to IEC 62304
  • A detailed overview of the challenges for ME Systems
  • EMC challenges in complying with IEC 60601-1-2

 

 

To book this course or discuss customised training, please email us at info@lorit-consultancy.com or call us on +44 7708 360023 or +43 676 338 8884.

 

We are also offering a variety of other courses in Salzburg or Edinburgh for the medical device industry, such as IEC 62304, ISO 14971 and IEC 62366-1. To secure your place on any of our training courses, for more information about the courses, or to find out how we can work specifically with your organisation and develop in-house training for your team’s individual needs, please contact us at info@lorit-consultancy.com