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The latest from HSD
The Value of ISO 13485 in a Design Centric, Medical Product Development Firm
What is ISO 13485? This is the easy part; ISO 13485 specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devicen development and related services that consistently meet customer and applicable regulatory requirements (from ISO.org). Any company can have a quality management system, but certification […]
Read MoreUpcoming Events
See AllHuman Factors Workshop – Current Best Practices
Medical Device Human Factors Workshop & Evening Networking Event at the Museum of London
More infoVisit HSD at MD&M East New York NY – June 12-14 2018
Visit us on June 12, 13, or 14th at the Jacobs Javits Convention Center, Booth #1863.
More infoHSD Exhibiting and Speaking at BIOMEDevice April 18-19, 2018
Join HSD at Booth #302 at New England’s largest event for Medtech professionals.
More infoRecent News & Events
See AllHSD wins prestigious 2018 EPDA Gold!
The VECTRA WB360, the world’s first 3D whole-body imaging solution, won a Gold Medical from the 2018 European Product Design Award. Designed for medical use, this innovative system images the entire skin surface in macro-quality resolution with a single capture. Integrated software allows clinicians to map, measure and track pigmented lesions and to record and […]
More infoHSD achieved transition to ISO 13485:2016
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 […]
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