Boyd Technologies has announced the certification of its quality management system to ISO 13485:2001.
ISO 13485:2001 is an internationally recognized quality standard to ensure the consistent design, development, production, installation, and sale of medical devices are safe for their intended purposes. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
“Attaining our ISO 13485:2016 certification is a major milestone as it speaks to Boyd’s continuous focus on risk management and design control activities during product development and commercialization,” commented Stephen Boyd, CEO.
About Boyd Biomedical
Boyd Biomedical is a commercialization partner for biomedical innovators. The Company's growth platform provides an integrated suite of services to help clients design, build, and launch biomedical devices.
Boyd is ISO 13485 certified, and FDA registered as a contract design and manufacturing organization for medical devices. The Company has three locations, its Headquarters and Build hub in Lee, Massachusetts; its Design hub in Waltham, Massachusetts; and its Launch hub in Boston, Massachusetts. The Company was founded in 1979 and is privately held. For more information about Boyd Biomedical, visit www.boydbiomedical.com.