ISO 13485:2016 Certification for medical devices strengthens Bittium’s offering for the health sector
Bittium Corporation has been awarded the ISO 13485:2016 certificate for medical device manufacturers. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Bittium offers services and technology expertise for wireless devices, network infrastructure, and IoT solutions in various sectors; including telecom, industrial and healthcare. The company also conducts R&D in the technology areas of 5G, Artificial Intelligence (AI), Robotic Process Automation (RPA), and Cloud Solutions. Medical technologies combined with strong expertise in wireless technologies enable Bittium to offer its customers in the healthcare sector new R&D services that meet the quality system standard requirements.
“Compliance with the quality system ISO 13485:2016 standard is a major competitive advantage for us; and we aim to utilize the certificate to expand the customer base in accordance with our strategy. Along with our new medical unit, we got a team of healthcare experts, and with their help we have succeeded in building the foundation for the development of medical products and solutions. The certificate allows us to offer more value also to our existing customers by introducing a bigger role in R&D projects,” Klaus Mäntysaari, Senior Vice President, Connectivity Solutions at Bittium said.
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.
Senior Vice President, Connectivity Solutions & Head of Technology Development