BioMelbourne Network member Design + Industry (D+I) is proud to announce that they have achieved ISO 13485:2016 certification — the culmination of a four-year effort and recognition of their commitment to design and engineering excellence in the development of medical devices.
With regulatory requirements becoming increasingly stringent, ISO 13485:2016 certification guarantees that D+I’s quality management processes meet the internationally agreed standard for the medical devices industry. D+I is one of the first product development consultancies in Australia to achieve this certification.
“D+I have been delivering complex medical devices for over 30 years. Receiving ISO 13485:2016 certification is recognition of the quality processes we have adopted at D+I and is a direct reflection of our commitment to best practice in design and engineering for the medical device industry,” says David Jones, Head of D+I.
Source: Design + Industry