Tooling Specification procedures

Tooling management is an urgent need for the efficient medical device manufacturing environment. Accurate functioning of instruments, gauges, apparatus, and recording devices is critical for the smooth flow of processes and maintaining safety standards. Therefore, the FDA has mandated a written record for the routine calibration of such equipment as well as the retention and maintenance of these records.  

ADB’s tooling specification procedures define detailed instructions to manage the fixtures, machines and equipments used in the manufacturing of medical devices. With years of experience working in rigorous FDA and ISO environments, ADB has developed immense expertise to meet the challenges of compliance. As part of our complete approach to compliance, we offer an automated, streamlined corrective action to increase the effectiveness and efficiency of your industrial equipments.

We ensure that your equipments, devices and fixtures are numbered uniquely and have the history of calibration and preventive maintenance measures in place. Our equipment calibration software system manages calibration tasks, calibration schedules and calibration data for FDA inspections. Besides the obvious quality benefits, our tooling specification procedures also help minimize downtime in manufacturing and laboratory operations.

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