International product design company, IDC (Industrial Design Consultancy), has announced it has transitioned to the medical device standard, ISO 13485:2016.
Projects director, Brian Gough, said: “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.
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 approach to design has proved 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 cycle.
ISO 13485:2016 addresses the development, implementation and maintenance of a quality management system for medical device manufacturers and suppliers.
The standard details how customer specifications and relevant regulatory requirements should be incorporated within an organisation’s quality management system.