“Achieving the ISO 13485:2016 certification validates our efforts to live Creation’s purpose of enriching lives,” said Creation’s President & CEO, Arthur Tymos. “It also demonstrates Creation’s strong team and robust customer and quality-focused operations, as we strive to exceed regulatory requirements for all of our customers in the medical community. This commitment to excellence is what drives our continued success in all of the markets we serve.”
The ISO 13485:2016 certification is a quality management system for the design, development, production, and installation of medical devices. In order to attain certification, a company must demonstrate evidence of compliance with strict processes including solid management commitment and highly effective production and quality controls.
Other Creation locations with ISO 13485:2016 certification include facilities in BC and Ontario, Canada, and Texas, Kentucky, Wisconsin, and Minnesota in the USA. Creation’s site in Changzhou, China, expects to receive certification later this year.
Creation currently provides PCBA and full-integration services to more than 30 medical customers whose products include Ultrasound Systems, Cardiology & Neurovascular Intervention, Speech Recognition Devices, Blood Processing Technology, EMG & EEG Diagnostic Equipment, Mass Spectrometers, Infrared Spectroscopy Devices, Dental X-Ray and RFID Security Solutions. Creation also provides product design and after-market services to its medical customers.
