The current understanding of software in medical engineering must be extended by the relatively new idea of stand-alone software: Where in the past the software was an integral part of a medical device, such as e.g. the firmware of a diagnostic device, stand-alone software now forms an IVD medical device on its own.
Stand-alone software also brought about new types of device delivery. Stand-alone software is for instance offered as an app for download in an app store or stand-alone software is delivered on a data carrier. Hardware is no longer delivered with stand-alone software.What’s so special about stand-alone software?As IVD software actually is the IVD, it must be validated. Especially in case of distributed systems (e.g. an app that requires a server for processing the actual calculation to function) a clear definition of the IVD medical device is very important but sometimes very challenging. Often it is helpful to have an external trained eye look at the IVD medical device to develop a clear definition together.
Stand-alone software also brought about new types of device delivery. Stand-alone software is for instance offered as an app for download in an app store or stand-alone software is delivered on a data carrier. Hardware is no longer delivered with stand-alone software.What’s so special about stand-alone software?As IVD software actually is the IVD, it must be validated. Especially in case of distributed systems (e.g. an app that requires a server for processing the actual calculation to function) a clear definition of the IVD medical device is very important but sometimes very challenging. Often it is helpful to have an external trained eye look at the IVD medical device to develop a clear definition together.
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IEC 62304
Defines the life cycle requirements for medical device software. The series of processes, activities and tasks described in this standard provide a common framework for life cycle 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. Its primary focus is on the requirements for manufacturers. It covers the entire life cycle including design, development, validation, installation, maintenance, and disposal of health software products.
Defines the life cycle requirements for medical device software. The series of processes, activities and tasks described in this standard provide a common framework for life cycle 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. Its primary focus is on the requirements for manufacturers. It covers the entire life cycle including design, development, validation, installation, maintenance, and disposal of health software products.
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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.