This book offers all countries a guide to implementing verification
systems for medical devices to ensure they satisfy their
regulations. It describes the processes, procedures and need for
integrating medical devices into the legal metrology framework,
addresses their independent safety and performance verification,
and highlights the associated savings for national healthcare
systems, all with the ultimate goal of increasing the efficacy and
reliability of patient diagnoses and treatment. The book primarily
focuses on diagnostic and therapeutic medical devices, and reflects
the latest international directives and regulations. Above all, the
book demonstrates that integrating medical devices into the legal
metrology system and establishing a fully operational national
laboratory for the inspection of medical devices could
significantly improve the reliability of medical devices in
diagnosis and patient care, while also reducing costs for the
healthcare system in the respective country.
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