Development and use of analytical quality specifications in the in vitro diagnostics medical device industry

Manufacturers of in vitro diagnostic (IVD) medical devices have become inte gral partners with their customers in determining the quality of laboratory results. Design controls imposed by ISO 9001 quality system standards and various regulations require manufacturers to implement a formal design proc ess, which begins and ends with customer requirements; For IVD systems, thi s means that manufacturers must establish analytical quality specifications as part of their design input. This provides greater assurance that commer cial products will satisfy customer requirements. In the case of quantitati ve IVD measurement systems, analytical quality specifications include total allowable uncertainty (bias, imprecision, non-specificity). The primary so urce of customer requirements is the laboratory-customer, who should have e stablished analytical quality specifications based on the needs of its phys ician-clients. The total allowable uncertainty budget is allocated in the d esign process to the individual components of the system, such as reagents, instrumentation, calibrators and accessories, and to other factors such as operator, specimen and environmental interactions. Their performance must collectively meet the total allowable uncertainty specification when they a re finally integrated into a measurement system. The design control model r equires objective evidence that design specifications have been met (verifi cation) and, finally, that the system will satisfy the needs of its intende d users (validation). Compliance with the quality system standards is monit ored through independent audits, government inspections and post-market sur veillance.