ISO 13485:2016 Certification supports the offering of Bittium’s design and product development services to the healthcare and medical sector
Oulu, Finland, September 12, 2017 – Bittium Corporation has been awarded the ISO 13485:2016 certificate, which covers the design, development, manufacturing and related services for the entire product life cycle of medical devices. The quality management system based on ISO 13485:2016 standard supports Bittium’s strategy for Connectivity Solutions’ product and service area. Medical technologies combined with strong expertise in wireless technologies and security provides Bittium with excellent opportunities to serve its customers in the healthcare sector with offering them new R&D services that meet the quality system standard requirements.
ISO 13485:2016 Quality Management System Standard is an updated version of the previous ISO 13485:2003 standard. It has been in use already from the year 2005 at Bittium Biosignals Ltd (formerly Mega elektroniikka Ltd), a healthcare company previously acquired by Bittium. The new certification complements Bittium’s existing certifications for ISO 9001:2015 quality system standard, ISO 14001:2015 environmental management system standard, ETC + energy efficiency system standard, and AQAP2110 ed. 3 quality system standard.