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.
Bittium, Tutkijantie 8, FI-90590 Oulu, FINLAND, +358 40 344 2000, +358 8 343 032,
www.bittium.com, VAT number: FI10041295, Business ID: 1004129-5, Oulu
Senior Vice President, Connectivity Solutions & Head of Technology Development
Tel. +358 (0)40 3443507