The current understanding of software in medical engineering must be extended by the relatively new idea of standalone software: Where in the past the software was an integral part of a medical device, such as e.g. the firmware of a medical device, standalone software now forms a medical device on its own.Standalone software also brought about new types of device delivery. Standalone software is for instance offered as an app for download in an app store or it is delivered on a data carrier. Hardware is no longer delivered with standalone software.A clear definition of the medical device may be difficult in many cases due to the standalone software's architecture (e.g. a distributed system with a server-client architecture).Do you have questions about standalone software? We are happy to answer them!
What makes us unique? We support you in ANY regulatory task of your development process. This is our holistic commitment.
What’s so special about standalone software?
As standalone software actually is in itself the medical device, it must be validated. Especially in case of distributed systems (e.g. an app that requires a server processing the actual calculation to function) a clear definition of the medical device is very important but sometimes very challenging. Often it is helpful to have an external trained eye look at the medical device to develop a clear definition together.We cleverly interweave the aspects of information security with the process so that your networked devices comply with the current MDR requirements.Our services in this field
Software as a medical device represents a great challenge for many manufacturers. As your service provider we will:
As a holistic service provider we are there for you to find answers to any question relating to risk management in accordance with ISO 14971 as well as usability in accordance with IEC 62366 (IEC 62366 and IEC 62366-1) and design the processes in close cooperation with you.
Also in terms of information security you can expect full regulatory support from us.
- Provide support already in categorizing the software correctly from a regulatory point of view,
- Define the development process with respect to normative requirements of IEC 82304 and IEC 62304 and
- Be at your side for solving all regulatory tasks throughout the development process.
As a holistic service provider we are there for you to find answers to any question relating to risk management in accordance with ISO 14971 as well as usability in accordance with IEC 62366 (IEC 62366 and IEC 62366-1) and design the processes in close cooperation with you.
Also in terms of information security you can expect full regulatory support from us.
All standard?
IEC 62304
defines the lifecycle requirements for medical device software. The series of processes, activities and tasks described in this standard provide a common framework for lifecycle processes of medical device software.
defines the lifecycle requirements for medical device software. The series of processes, activities and tasks described in this standard provide a common framework for lifecycle processes of medical device software.
IEC 82304
applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers. It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.
applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers. It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.