HS Design Receives ISO Certification

HS Design Inc. has received ISO 13485 and ISO 9001:2008 certification, which certify a comprehensive management system for the design and manufacture of medical devices, and a satisfactory quality management system (QMS) respectively.

“HS Design’s overarching goal is to ingrain continuous improvement within our QMS so we are constantly improving the value and integrity of our products and services. This certification demonstrates to our clients that HS Design is strongly committed to quality,” said Robert Barry, director of engineering, HS Design Inc. “It shows we are maintaining product engineering standards to provide clients with the best possible service. The work that went into achieving this milestone brought our design and engineering teams closer together. We did not want to create a system that threatened the innovation and creativity process, but needed a system that could manage design control. We developed our process to allow for creativity to be managed as it moves through engineering.”

HS Design has been providing research, design and development of medical products for more than 40 years.

“We have always strived to meet the the U.S. Food and Drug Administration’s (FDA’s) quality guidance documents,” said Tor Alden, principal of HS Design. “This certification aligns HS Design’s management system to the requirements of the FDA’s quality system regulation requirements and meets the globally recognized ISO requirements for the design and development of medical products. Most of our clients and partners are ISO-certified. It was a logical step for us to align our QMS standards with those of our clients and partners.”

Located in Gladstone, N.J., HS Design is a full-service product development and design firm for the medical and life-science industry. The company focuses on contextual research, market strategy, industrial design, packaging, mechanical engineering, electronics, software, finite element method simulation, prototyping, verification and validation testing, and manufacturing.