We’re happy to announce that 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 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 and demonstrates our commitment to secure and user-driven design. The QMS development and certification process has proven a valuable experience as we transition to our own product, helping us understand medical device development and its standards on a deeper level.
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 to ensure best possible quality, as well as worked on the processes for utmost efficiency and safety. The accomplishment proves we are not only on track but take regulatory compliance seriously as we work on improving patient safety in the healthcare sector.Miikka Kirveskoski, CTO, NE Device SW
An audited QMS proves NE Device SW a reliable partner for business and research, capable of delivering secure, high quality medical software.