Compliance to Quality Management System ISO 13485:2016 standard for Medical Devices is a major competitive advantage, which supports Bittium’s strategy in the Connectivity Solutions’ product and service area.
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.
“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,” says Klaus Mäntysaari, Senior Vice President, Connectivity Solutions at Bittium. “The certificate allows us to offer more value also to our existing customers by introducing a bigger role in R&D projects”.
ISO 13485:2016 standard
ISO 13485:2016 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. The standard is intended specifically for medical device manufacturers. The main goal of the standard is to provide a harmonized model for quality management system requirements. ISO 13485:2016 standard is based on the quality management system standard ISO 9001:2008.
Bittium is a trusted design and development partner, offering its design services and technology expertise for wireless devices, network infrastructure, and IoT solutions in various sectors; including telecom, industrial and healthcare. Bittium also conducts R&D in the technology areas of 5G, Artificial Intelligence (AI), Robotic Process Automation (RPA), and Cloud Solutions. Bittium’s competitiveness in these markets is based on strong technology and security expertise and an established reputation for reliability and quality.
In its Medical Technologies product and services area Bittium provides among others Bittium Faros product family, focused on ECG recording and remote monitoring, Bittium NeurOne products focusing on measuring the electrical activity of the brain, and Bittium BrainStatus, a disposable quick EEG measuring headband used in emergency and intensive primary care to diagnose for example epileptic seizures and brain stroke, and other healthcare technology products. Bittium continues to develop these products further targeting to grow its product and service offering to healthcare and homecare markets.
Senior Vice President, Connectivity Solutions & Head of Technology Development
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Bittium specializes in the development of reliable, secure communications and connectivity solutions, leveraging its 30 year legacy of expertise in advanced radio communication technologies. Bittium provides innovative products and services, customized solutions based on its product platforms and R&D services. Complementing its communications and connectivity solutions, Bittium offers proven information security solutions for mobile devices and portable computers. From November 2016 onwards, Bittium offers its customers also healthcare technology products and services in biosignal measuring in the areas of cardiology, neurology, rehabilitation, occupational health and sports medicine. Net sales in 2016 was EUR 64.2 million and operating profit was EUR 2.5 million. Bittium is listed on Nasdaq Helsinki. www.bittium.com .