IDC is delighted to announce it has transitioned to the medical device standard, ISO 13485:2016, seamlessly with conformity throughout the quality process.
Projects Director, Brian Gough, comments, “It’s quite an accolade to achieve a completely clean sheet during auditing, with no non-conformities, and this goes to show just how far our quality processes have developed at IDC.”
The ISO 13485:2016 certification applies to the whole of IDC’s organisation, and includes its product design studio, prototyping and production unit in IDC Models, as well as IDC China in Shanghai. Unlike many consultancies who work purely on the design side, IDC is able to meet the toughest quality requirements at all stages of the design process, as the product moves through the development from design to prototyping and production. As a result, IDC can provide a level of quality assurance that is unique amongst competitors.
Safety and quality are of paramount importance when developing medical products. Regulatory requirements are also becoming increasingly stringent throughout every step of a product’s lifecycle, including quality and service. IDC has developed its own design process over the last 46 years and this analytical approach to design has proved highly successful, particularly for medical products. The process enables the team to identify risks and respond to any potential challenges, consider regulatory aspects at all stages and guide clients through the development to ensure commercial success for clients. ISO 13485:2016 in combination with ISO 13785:2016 and ISO 9001:2015 provides further assurance and highlights IDC’s commitment to best practice for the future.