The NE Device SW Quality Management System (QMS) used in development of Vitacam remote monitoring solution has been audited and subsequently certified by SGS Fimko Ltd. according to the ISO 13485:2016 standard. The certification was granted for design, development, testing, production and distribution of standalone medical software for measuring vital signs. In addition to ISO 13485, the QMS also incorporates elements of other relevant international standards including ISO 14971, IEC 62304 and IEC 62366.
As the international QMS standard for medical devices and equipment, being ISO 13485 certified is a mandatory requirement for any company looking to design, develop or sell medical device software. A certified quality system ensures that the full development process and tools used are compliant with set regulations and the organization is capable of consistently meeting customer requirements, in addition to responding to the latest system practices. The goal of the standard is to ensure patient safety by guaranteeing the quality and security of a medical device.
Being ISO 13485 certified serves as an important step for NE Device SW and Vitacam. It demonstrates the company’s commitment to a secure and user-driven design.
‘The QMS development and certification process has proven a valuable experience as a transition to our own product, helping us understand medical device development and its standards on a deeper level. We believe that an audited QMS demonstrates that NE Device SW is a reliable partner for business and research, capable of delivering secure, high-quality medical software,’ said Miikka Kirveskoski, CTO at NE Device SW.
‘The committed and talented team has excelled in overcoming the Vitacam solution development and verification challenges by developing state-of-the-art mechanisms for our technology. This, in turn, ensures best possible quality, efficiency and safety. The accomplishment proves we are not only on track but we also take regulatory compliance seriously as we work on improving patient safety in the healthcare sector,’ Kirveskoski concluded.
About NE Device SW:
NE Device SW Ltd. is a software development company based in Oulu, Finland. Since its establishment in 2014, the company has grown into a versatile and diverse group of 18 industry professionals, delivering software for smartphones, sports-watches, health devices, cameras and more.
In 2019 NE Device SW participated in the EU funded project, inDemand, answering the Health challenge with its respiratory rate monitor that uses computer vision and digital cameras. The solution, now known as Vitacam, has since grown in scope, incorporating pulse measurements and offering supporting technology for logging results and managing workflow. Due to its software-based nature, Vitacam scales to healthcare needs of any size, with no specialized hardware or direct contact with the patient needed. Vitacam has been co-developed with Oulu University Hospital, with an active pilot running with real patients since summer 2020. The company is also working with the University of Warwick in the UK to develop a digital care pathway for patients with severe respiratory diseases.
NE Business (CEO)