In this article, we’ll try to consider various aspects of validation of software for medical devices.

Nowadays, more and more medical devices that are being entered into the market includes software or are represented by a program product without hardware components. These medical devices, as a rule, are equipped with a user-friendly interface and are characterized by an extended functionality, especially regarding interpretation and visualization of the process of medical procedures.

At the same time, use of software as a component of the medical device, as well as production of medical devices that are software themselves, imposes some risks of incorrect operation of the software and, as a consequence, possibility to do harm to the health of the medical personnel and/or the patient. For example, if the software of a biochemical analyzer interprets the received results with errors, it can lead to establishing of a false diagnosis that provokes choice of incorrect treatment plan and, as a result, leads to decrease of the patient’s health state, even to the patient’s death.

In one of our previous articles on validation of sterilizing process for medical devices we have noted that not all the parameters of medical devices can be inspected during their serial production, and we considered such a parameter as sterility. One more parameter that can not be inspected during acceptance testing is stability of operation of software for the check of stability of program operation requires a significant amount of time and resources that make it impossible to perform inspection for serial production.

Thus, in cases when the scope of the medical device includes software and the medical device itself is a autonomous software product, the manufacturer should assure correctness and stability of operation of the software, check and confirm that there are no critical errors in the program code that can influence quality, safety and efficiency of the medical device at serial production. The abovementioned inspections should be performed during the process of validation of software for medical devices.

Considering the importance of the requirements to correct operation of the software for medical devices, the regulation authorities for trade of medical devices demand that the manufacturers during registration process submit the documents that confirm validation of the medical software. In the Russian Federation, the requirements to submit the documents on validation of software are established by para. 18 of section 4 of the Order of the Ministry of Healthcare of the Russian Federation dated the 19th of January, 2017, No. 11n «On statement of the requirements to content of technical and operational documentation made by the manufacturer (vendor) of a medical device». On the territory of the EAEU, this requirement is given in section 24 Of Appendix No. 4 to the Rules of registration and expertise of safety, quality and efficiency of medical devices (established by the Resolution of the Eurasian Economic Commission Council No. 46 dated the 12th of February, 2016).

Thus, registration of medical devices (both according to the national rules and within the frames of EAEU) that contain software in their scope or that are software products themselves is impossible without validation of software.

Validation of software is the process of confirmation of serviceability of the software to provide performing of specified functional operations.

To achieve this goal, the validation process should solve the following tasks:

  • Identification of the software (name, number and date of the version);
  • Check of compatibility of the operational systems and hardware, their identification (when used);
  • Confirmation that the software provides functionality of the medical device in full accordance with the technical and operational documentation;
  • Confirmation that the software do not lead to critical failures, including those possible in the extreme load modes (duration of the device use, mechanical loads applied to the device, speed and intensiveness of operation, vibrational loads, instability of power supply voltage, etc. according to the device, standard conditions of its use and matter of use);
  • Confirmation that the software interface declines the possibility of entering of incorrect or sudden commands in cases when it can do harm to the treatment or diagnosis process to the minimum.

Considering that the software developers in general cases are the party of interest as regards positive results of validation, it is recommended to choose a third organization to perform validation. When this is not possible, validation is recommended to be performed by personnel that has not been directly involved into development of the software, for example, by the specialists of the quality control sevice.

Validation of medical software is performed according to the program that, as a rule, is developed by an authority that performs validation together with the developer (manufacturer) of the software. Program of validation of software contains the following information:

  • Version and date of validated software;
  • Scope, terms and methods of inspections;
  • Persons responsible for validation;
  • Requirements to recording of the test results.

In general cases, the results of validation performed according to the program are recorded as a report and documented act. In some cases (for example, for simple devices) it is allowed to issue only a documented act.

The documented act and the report on validation should contain the results of performed inspections and conclusions on serviceability of the software for solving the certain practical tasks. It is allowed to apply photos (or screenshots) of the operation results of the software that demonstrate correct performance of the user commands for visualization of the results.

There are no strictly established forms of the program, the report and the documented act on validation of software for medical devices. That’s why the person of responsibility should develop the forms of the abovementioned documents by himself/herself on the basis of the recommendations of international and state standards, both general and applied to a certain software product.

The main standards that should be followed are GOST R MEK 62304-2013 Medical devices. Software. Life cycles processes (IEC 62304:2006 «Medical device software – Software life cycle processes»), GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices (ISO 14971:2019 Medical devices – Application of risk management to medical devices). These standards determine the main risks that should be inspected during the validation process, but the standards do not contain the methodology of validation performance. Development of the methodology is the duty of a person responsible for validation of the software.

In case, when after validation the software has been reworked or changed, the repeated validation is required. The scope of inspections in this case is determined by the changes in the program code. At the same time, if the person responsible for validation decides to reduce the scope of inspections relatively to the primary validation, it should be clearly explained and approved.

Validation of software is one of the key stages required for release of active medical devices that comply with the requirements to quality, safety and efficiency to the market. Formal performance of validation of software just for documents can lead to critical failures during the process of use of medical devices and, as a result, serious problems for both the patients and the medical personnel.

Validation of software should consider all the aspects associated with use of the medical device in real conditions of medical aid provided for the patients that requires that the persons responsible for validation should have a great experience at various fields: development and testing of software, designing and manufacturing of medical devices, as well as practical aspects of their use.

If you have any questions regarding validation of software for medical devices, you can address to our experts for consultation. Our expert personnel includes the candidates of technical sciences, experts at development and testing of software, members of expert committees of leading manufacturers of medical devices and experts at validation of software for medical devices.