Hosiden Besson Ltd (HBL) is thrilled to announce we have achieved the medical device quality standard ISO 13485:2016 certification. This demonstrates our commitment to the highest levels of quality management and enables us to better serve medical device manufacturers with our subcontract manufacture and repair services.
As an OEM, ODM and subcontract manufacturer, the ISO 13485 certification allows HBL to expand into the medical device market. It shows potential new and existing customers that we can manufacture compliant products of the highest quality in a strict regulatory environment.
HBL worked diligently to integrate the medical standard into our existing ISO 9001, 14001, and IATF 16949 certified quality management systems. Achieving ISO 13485 certification was a team effort, and we thank our staff and consultant Samantha Shelley for their hard work.
Managing Director Donna Vye said, “Adding ISO 13485 to our QMS portfolio shows our commitment to pursuing quality and growth. We look forward to new opportunities in the medical manufacturing sector.”
If you have a medical device prototype which you’d like to take into production, don’t hesitate to contact us.