Overview of Medical Equipment Software and Its Testing Algorithms

Medical application is software developed for use in the field of medicine, used by both medical personnel (for example, doctors, less commonly, junior medical workers) and patients.

Applications are designed to work with them in different areas of medical services, so the functional characteristics of each of them vary significantly. These can be both custom healthcare software development services specifically for narrow-profile clinics, and for the entire medical industry as a whole.

Products that are designed to collect and store patient information are important, but such applications must be provided with a high level of security so as not to reveal personal information about the patient. When testing medical software, the algorithm of work does not differ significantly from work in other areas. It only has rad features using interactive methodology methods.

How to test medical software? 

Testing services for medical software is the process and result of the work of a specialist in testing this product. The developer must ensure the smooth operation of the application, and the tester must eliminate any errors.  

Such software products are a tool for medical professionals that simplifies the work of diagnosing and prescribing a particular drug, taking into account its dosage. Medical software testing covers the storage and processing of personal data, which requires a high level of protection.

The tester must make sure that there are no critical errors in the code. There are repositories of personal and clinical data. And when testing, it should be borne in mind that these are two different processes, so when checking, it should be possible to query from the database bypassing authorization.  

Digicode underlines that when developing medical services, the interests of users should be taken into account. Verification should be carried out by the user, and then write test scripts.

This is isolated by the fact that such services have specific content, which requires a specialist to study in more detail and identify the relationship between the parameters, and only after that carryout manipulations regarding the verification of this product.  

A poorly tested or faulty software product cannot be released to the market. This can lead to undesirable processes, both on the side of the user and on the side of the development team, including QA engineers, and suppliers.

This can lead to fines and damage to your reputation. Qualitative testing is carried out by:  

• studying the specification, which should take into account all technical characteristics;
• including the description and use of the product; determine the conditions in compliance with the software.

Particular attention should be paid to testing all levels:  

• software verification (testing the conditions and requirements for the product being developed, the use of automation and continuous testing, productivity tests, etc.); 
• verification requirements for software (testing security, functionality, etc.);
• software design verification requirements (testing security and design standards, verification of specifications for accuracy and compliance);
• code verification (testing documented product requirements, using methods to identify defects and bugs, analyzing and checking the quality of the source code); 
• use of single testing; compliance testing requirements.

Medical software validation

Software validation is the process of confirming the suitability of the software for specific applications.  

To achieve this goal, the following tasks should be solved in the validation process:  

• software identification (name, number, and version date);
• checking the compatibility of operating systems and hardware, and their identification (if applicable);  
• confirmation that the software ensures the functioning of the medical device, in full compliance with the technical and operational documentation;
• confirmation that the software does not lead to critical failures, including in limiting load conditions (duration of product use, mechanical loads on the product, speed, and power of operation, vibration loads, power surges, etc. depending on the product, regulatory conditions of its operation and purpose);
• confirmation that the software interface minimizes the possibility of entering erroneous or inadvertent commands in cases where this could adversely affect the treatment or diagnostic process.

Peculiarities of medical software validation

Considering that software developers are generally considered to be a party interested in a positive result of validation, it is recommended to entrust its implementation to an external organization, and if this is not possible, then to employees who were not directly involved in software development, for example, quality service specialists.

Validation of medical software is carried out in accordance with the program, which, as a rule, is developed by the organization conducting the validation, together with the developer (manufacturer) of the software. 

The software validation program contains the following information:

• version and date of the software being validated;  
• volume, terms, and methods of checks;  
• persons responsible for the validation;  
• requirements for registration of test results.  

In general, the results of the validation carried out following the program are documented in the form of a protocol and an act. In some cases (for example, for simple devices) it is permissible to confine ourselves to only an act.

The validation act and protocol should contain the results of the checks carried out and conclusions about the suitability of the software for solving specific applied problems. For clarity, it is allowed to attach photographs (or screenshots) of the results of the software operation, demonstrating the correct execution of user commands.

There are no strictly regulated forms of the program, protocol, or act of software validation for medical devices. Therefore, the responsible person needs to independently develop the forms of the above documents, taking as a basis the recommendations of national and international standards, both general and applicable to a specific software product.

Conclusion

Software validation is one of the key steps required to bring active medical devices to the market that meet quality, safety, and efficacy requirements. Formal software validation can lead to critical errors in the process of using medical devices and, as a result, the onset of adverse events, both for patients and for medical personnel.

Software validation should take into account all aspects associated with the use of a medical device in real-life patient care, which requires those responsible for conducting validation to have extensive experience in various areas: software development and testing, design and manufacture of medical devices, and as well as practical aspects of their application.

If you have any questions related to the validation of software for medical devices, you can contact Digicode experts for advice.