Software as a Medical Device – Graylight Imaging is now ISO 13485  

November 2023 marked the end of the long road we went through to be certified to ISO 13485:2016. Exactly two weeks ago, an external audit took place, as a result of which TUV NORD auditors found no non-conformities, which means the way is open for us to be certified. We started reviewing and adapting our processes to ISO 13485:2016 in January 2023, so the almost year-long project of working on the Quality Management System has had the desired effect.  

The Purpose of ISO 13485 at Graylight Imaging

Graylight Imaging specialises in producing software for medical device manufacturers, specifically relating to medical imaging and numerical analysis. Despite our competence and experience, we recognised our customers’ need for us to be certified to the ISO 13485:2016 standard. The software and its documentation we supplied met the ISO 13485:2016 criteria and enabled our customers to obtain CE certification for their medical devices and bring them to market. Sometimes, however, they had to do additional work and submit more documentation to demonstrate that all the work we carried out was compliant with the regulations. Having us certified to ISO 13485:2016 solves this problem, as the compliance of our software development processes with the regulations has already been verified by an independent, external audit 

QMS standard for medical device development

Graylight Imaging has had a Quality Management System in place since almost the beginning of its existence in 2016, first as a department within Future Processing S.A. and since 2021 as a subsidiary. This means that we have 7 years of experience in producing software for medical devices in accordance with current standards. All the experience and good practices we have gathered during this time are reflected in the processes and procedures included in our Quality Management System. We know from experience that, over time, the QMS can start to diverge from the activities actually performed by employees, and the procedures contained therein are no longer valid. Such a ‘dead’ QMS no longer fulfills its role, and the organisation runs the risk that the products it produces will not comply with regulations. A common reason for this is that the QMS is dealt with by too narrow a group of employees, often not close enough to the processes operating in the company or department concerned. GLI’s response to this problem is to appoint a process owner for each process—a person close to the process in question, most often the head of the department implementing it. He or she becomes the owner of the process in question. He or she ensures not only that the QMS records are up-to-date but also that they are followed in practice. In addition, this is verified during internal audits. This approach enables us to provide our customers with software and documentation that complies with current standards.

The advantages of high-quality standards

Working in compliance with standards is always well appreciated. This truism is particularly applicable in the healthcare industry, as the products we make serve patients. Their purpose is to prolong their lives through effective diagnosis and subsequent treatment. At GLI, we carry out our work with the greatest care. By this we mean not only the quality of the code we produce and the documentation describing the work carried out but also the safety risk analysis from the patient’s point of view and the usability of the medical device from the user’s point of view. This approach allows us to undertake work on medical devices that are difficult and have a major impact on the patient’s treatment process. We are convinced that maintaining high standards during our work not only allows us to ensure the high effectiveness of medical devices but also makes them safe for patients. An additional advantage of this approach is that the software we provide is extensively and meticulously tested. This ensures that the number of errors and failures is very low and occurs mainly due to factors external to and beyond the control of the software. 

Trust GLI engineers as a high-quality tech partner

Working to the highest standards and regulatory compliance makes GLI a reliable partner for medical device manufacturers. The software and image processing algorithms we provide are characterized by high performance and safety for the patient and user. Adhering to the highest standards is valued by all our customers, who are often very different from each other. We work with their R&D departments on cutting-edge solutions, as well as jointly developing dedicated software for smartphone study consultations; this shows the range of our services. Our specialists in machine learning, DevOps, cloud solutions, testing, IT security, medical imaging, and business analysis support the development of our customers’ medical devices and products. Having a team with a wide range of competencies allows us to develop specialised software for medical devices: from web applications and cloud solutions through desktop applications to mobile device applications. We carry out the process of verifying the performance of the software we produce and support our clients during its validation in a real-world environment. We have a network of contacts among clinical experts from Poland and Europe who support our clients in the process of preparing data for AI models, testing, and evaluating the usability of medical devices. We maintain the already-released versions of medical devices and develop further versions by creating updates. All these activities are united by high diligence, adherence to ISO 13485:2016 standards, and the professionalism of our team.