IEC 62304
IEC 62304 Consultancy & Training
The team at Lorit Consultancy has many years of experience in the field of software development in the medical technology industry and is therefore a competent partner for the application of IEC 62304 Medical device software – software life cycle processes.
Whether you need consultancy, support or training – we support your team with our expertise in safe product design.
About IEC 62304
In healthcare, the use of software is becoming increasingly important and can contribute to more efficient and safe patient care.
The international standard IEC 62304 specifies requirements for software lifecycle processes – both for embedded and standalone software, such as for medical apps. The requirements relate to software development, maintenance, risk management, configuration management and problem-solving processes.
IEC 62304 relation to other standards
Risk management and control are integral parts of the IEC 62304 standard, which also refers to ISO 14971: Risk management for medical devices. Furthermore, usability and the respective standards IEC 62366: Usability engineering for medical devices and IEC 60601: Safety requirements for medical electrical (ME) equipment and in medical systems are taken into account in the development and use of software.
When developing standalone software – software that is to be brought to market without dedicated hardware – the standard IEC 82304-1: Health software – Part 1: General requirements for product safety also applies.
Our services
Consultancy & Support:
- Software risk analyses, metrics and cybersecurity
- Software reviews at system-, item- and unit level
- Writing work products such as the development plan, maintenance plan, configuration plan or specifications
- Implementation of the processes required by IEC 62304
- Creation and documentation of system and software requirements
- Implementation of the requirements for AI applications
- Implementation of the IEC 62304 requirements in agile software development processes
- Implementation of the processes or work products in software tools (e.g. Jira or Jama)
Trainings:
We offer (online) training courses that can be customised to meet your requirements in terms of date, format and content.
In our IEC 62304 Introductory course you learn the basics and in the IEC 62304 Advanced course the implementation and application of the standard with work examples, team exercises and our industry knowledge and experience. This training can be complemented by 4-hour workshop diving deeper into practical examples either brought by your team or prepared by Lorit.
You will be guided through the entire V-model from the requirements process to verification, and in our advanced course you will learn various methods and strategies for the implementation of your projects.
We will cover how to successfully implement the requirements of IEC 62304 in agile processes. Furthermore, topics of cybersecurity and AI applications are included in both training courses.
