MEDICAL DEVICES QUALITY ASSURANCE SERVICES

The main objective of the two tools described herein is the support of Quality Assurance of Medical Devices. The first tool is named PANDA a nd was developed for quality control services for inspection of Medica l Devices. PANDA is used directly in connection with inspection of a w ide range of medical devices. It functions as a dynamic quality manual which is able to carry out inspection procedures and contains a log f or each medical device containing measurement data and material used. Extended reuse of previous work and modular contruction assists in the construction and maintenance of the inspection procedures. The sequen ce of inspection instructions can be controlled by a logic language. O bject oriented programming is also used throughout for the database. T he tool is characterised by its ability to fully document the circumst ances under which the inspection is performed. This makes PANDA a cand idate for ISO 9000 work. The second tool is a European Database for Qu ality Assurance Data (EuroQADB). The purpose of the EuroQADB is the ex change of inspection procedures and inspection data gathered using PAN DA.