Unique Design and Development LLC has earned certification to ISO 13485:2003 and ISO 9001:2000 from BSI Management Systems. BSI develops, implements, registers management standards, and helps organizations gain accreditation that reflects improved business performance. The certification's scope is for contract design and development of medical devices including surgical instruments and implants. UDD's expertise lies in handling FDA requirements, QSR and ISO systems, and prototyping and testing capabilities.