K-Sky received a certificate for the quality management system according to the interstate standard

2023: Obtaining a certificate of compliance of the quality management system with the ISO standard 13485-2017

K-Sky, the developer of the Webiomed platform, received a certificate of compliance of the quality management system with the ISO 13485-2017 standard. Assessing the quality of the company's products will increase customer confidence. Skolkovo reported this on November 29, 2023.

The GOST ISO 13485-2017 standard contains a set of requirements for quality management systems of organizations whose type of activity is related to the production of medical devices.

In bringing to market and developing software medical devices using artificial intelligence technologies, there is an acute trust problem in the application of this technology due to the opacity of the medical device manufacturing process. QMS certification allows you to independently confirm that the company's business processes comply with a generally accepted standard, are developed on the basis of a risk-based approach and ensure quality control at all stages of product creation. This is an additional confirmation of the reliability of the company's products and increases customer confidence in them. said Roman Novitsky, CEO of Webiomed.

Organizations can obtain GOST ISO 13485 certification by passing the appropriate audit. According to the results of the certification audit of the Russian Expert company K-Sky, a RUSEXP-RU-000359 certificate was issued regarding the development, production, sale and maintenance of the forecast analytics and risk management platform in healthcare based on machine learning Webiomed.

Artificial intelligence is a key technology of the future, and Russia seeks to become one of the leaders in this area. Successful K-Sky certification is an important step in achieving this goal. It confirms a high level of competence in the development and use of artificial intelligence. We are confident that the development of K-Sky and its products will lead to an improvement in the technological and innovative potential of our country. We expect that the successful certification of K-Sky will be a good example for other companies, stimulating them to develop in the field of artificial intelligence, said Sergei Morozov, Development Director of Russian Expert.

We clearly see how rapidly artificial intelligence systems are developing and being introduced into practical healthcare. The key factor of success here is the trust on the part of the regulator, doctors and managers, which requires the implementation of an AI solution for the quality management system (QMS) by the developer. Our resident "K-Sky" previously received an international QMS certificate according to the ISO 13485 standard and now the company has passed certification according to the Russian standard, thereby confirming the presence of a QMS that meets all standards. noted Yulia Shcheglova, senior project manager of the Skolkovo Foundation biomedical cluster.

In 2022, K-Sky introduced and certified a quality management system (QMS) according to the international standard ISO 13485:2016. In March 2023, an independent certification supervisory audit was conducted by experts from the international company TÜV AUSTRIA, as a result of which the current certificate for compliance with ISO 13485:2016 was renewed.

Since June 1, 2018, the interstate Russia standard GOST ISO 13485-2017 "Medical Products. Quality management systems. Requirements for Regulatory Purposes, "similar to the international version of ISO 13485:2016. The standard provides for continuous monitoring throughout the life cycle of a medical product: from the design and development stage through all stages of production.