Complying with regulatory requirements is a daily activity for software developers in the medical device industry. With the requirements of IEC 62304 on the life cycle for the development of the medical software and software within medical devices certain demands are placed upon development teams. But it does not only need to have a standard to minimize risk, it needs people who are specialists in software development and with a good knowledge of how to implement, maintain and use those international standards.

Imagine creating a state-of-the-art medical device e.g. a new pacemaker where the misinterpretation of requirements or lack of rigour in verification could lead to potentially fatal results. Obviously, any risk of a potential error needs to be eliminated.

 

 

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 62304 and many other standards.

 

    

The Lorit Consultancy Team

 

 

Advanced course for advanced engineers

Our aim is to support our clients master the challenges of medical device software development. We recently set up an additional course for the medical device industry. Beside our existing IEC 62304 Introductory course we are now offering an IEC 62304 Advanced course designed for software, compliance and quality engineers with comprehensive technological knowledge. The course focuses on the challenges in software development – some of which have up to now not been covered in IEC 62304 – and offers a broad repertoire of methods and strategies to support them.

Risk management methods, agile software development and cybersecurity strategies – just to name a few. With this course engineers learn in a practical manner how to implement and use those tools in the context of their projects.

 

Please find the IEC 62304 Advanced course brochure with all details here.

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 60601-1, 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