On April 27th HS Design achieved its transition to ISO 13485:2016 through BSI. HSD, which was previously certified to the 2003 version of the standard, chose to transition to 2016 during its recertification year. ISO 13485:2016 is the international standard for quality systems used to design and manufacture medical devices.
The process involved a year-long effort to upgrade HSD’s quality systems to meet the new standard, which emphasizes a higher degree of monitoring and input controls than previous versions of the standard. For HSD, a product development firm, the idea of a “product” includes not only the actual device design but the development services themselves. Michael Quinn, VP of Design and Engineering puts it this way “The new standard requires us to look at all elements that can affect the design services we provide our clients. It has afforded HSD the chance to increase the quality of our work by being mindful of all the ways that work is generated.”
Achieving ISO 13485:2016 certification marks HSD’s commitment to the very best design and development services possible for the medical device community. HSD uses this QMS in Human Factors, Usability Research, UX/UI, Industrial Design and Engineering to help proper quality in the development of innovative medical products.