IDC China Achieves ISO 13485 & ISO 9001

Following the news that IDC (Industrial Design Consultancy) has achieved ISO 13485 and ISO 9001 certification, the international product design specialist has replicated such success at its Shanghai office – a rarity amongst international competitors with a presence in China, and other local product design businesses.

Over the last six years, IDC has witnessed the Chinese medical device market undergo a transformation with more and more manufacturers calling on the company to develop high quality products which are creatively designed for an international patient audience, but which also meet the stringent standards set by key regulatory bodies in terms of quality and compliance.

IDC China’s managing director, YiFei Dai, commented, “In a fast-growing healthcare market worth billions, product success and resulting profitability rely on quality. This fuels the demand for certification. Meeting the rigorous standards of ISO 13485 and 9001 represents our everyday quest for quality assurance in the design and development process. It is a real coup for us; we may even be unique in achieving it here.”

For medical device manufacturers who want to compete globally, ISO 13485 and 9001 are industry-recognised, critical stamps of approval that mitigate risk from the outset.

Dai continues, “We consider regulatory aspects throughout every step of a product development. We understand the demands of a global market, its respective patient populations, expert users and regulatory organisations. The ISO standards provide an ongoing methodology which is integral to the quality promise we make for every design we create, and it is essential in the process and delivery of the very best products.”

IDC China was set up in 2008, after establishing firm local knowledge and extensive work experience in Asia over the last 30 years. Having been hand-selected by the Department of UK Trade and Industry (UKTI) to join a 12-strong team of leading British design consultancies and capitalise on what was then an emerging market, IDC quickly established a solid reputation among Chinese companies requiring global support.

Since then, the international arm of IDC has gone from strength to strength, providing a rounded understanding of global markets, whilst also designing or modifying medical devices which consider subtle cultural distinctions and meet the needs of patients abroad, as well as regulators. It has also proved popular with UK companies wishing to break into Asian markets, or who require assistance in sourcing and managing Asian supply chains to reduce manufacturing costs by using IDC China’s on-the-ground experts and local knowledge.