Did you know that...
is Software Validation
in Medical Devices
Today, our colleagues from the consultancy firm Telstar have wished to take part in the 'Did You Know…' section from our blog.
To this end, they have decided to write an article that will give you an introduction to one of the regulatory issues they know best: the Software validation for medical devices.
We recommend that you make the most of this opportunity to find out more, with the help of Telstar’s healthcare technology experts, what are the main challenges posed by the validation process for software which, according to Regulations (EU) 2017/745 and 2017/746, they must be regarded either as medical devices in their own right or as components of a medical device.
What is software validation for medical devices?
For the validation of software in medical devices in accordance with the Regulations MDR 2017/745 and IVDR 2017/746, the standard is used IEC 62304 (UNE-EN 62304:2007). The IEC 62304 standard serves as a benchmark for the entire software lifecycle of medical devices (specification, analysis, development, validation, maintenance, etc.), as shown in Fig. 1.
Remember: This rule applies whether the Software that forms part of a medical device, such as where the Software is, in itself, a Medical Device.
The classification of software, in accordance with the standard IEC 62304 (UNE-EN 62304:2007), is based on the potential effects on the patient, operator or other persons resulting from a hazard that the software in the medical device may cause:
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Class A: There is no risk of injury or harm to health
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Class B: A NON-SERIOUS INJURY is possible;
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Class C: There is a risk of DEATH or SERIOUS INJURY.
Key Aspects of Software Validation in Medical Devices
According to Telstar, these are the main challenges to bear in mind when carrying out software validation for a medical device:
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In accordance with the regulation IEC 62304 and in accordance with the Medical Devices Regulation (MDR 2017/745 and IVDR 2017/746), Documentation must be provided to show thatit has validated the use of the software programmes, as used in the final product.
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It must be verified that the necessary measures have been incorporated into the design to ensure repeatability, reliability and performance in accordance with the system’s intended use and that these measures are working properly. The following must also be identified and detailed, cWhere applicable, the system reference databases.
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During development, the operation of the system’s functional elements must be verified through unit tests (Unit Test) and their interrelationship through joint tests (Integration Test).
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During validation testing, the correct implementation and functionality of each User and Software Requirement are verified (System Testing) and a simulated test of the system is carried out in a real-world environment (Simulated Test).
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Validation summarises the results of all the checks carried out to ensure that the system functions as intended in its actual operating environment