| Popis: |
Metrological assurance is decisive in medical equipment calibration and is indispensable in quality control and assurance, risk assessment, monitoring of the patients, diagnosis and treatment of patients. As a part of health care regulations, the biomedical equipment must demonstrate compliance with metrological traceability to SI unit chain through a chain of calibration, verification and certification on the performance of the equipment. In this context, CSIR-NPL is serving the country by providing calibration facilities traceable to SI units to support the quality regulation of Medical equipment. The Biomedical Metrology program at CSIR-NPL contributes enormously to the economic development and healthcare sector of the country by way of providing calibration and consultancy services to healthcare sector that includes accredited laboratories, regulatory bodies, hospitals and testing laboratories, etc. In this chapter, we have elaborated the role of regulatory bodies of India and National Metrology Institute, CSIR-NPL in context of the “New Medical Device Rule”. We also critically analyse the importance and implementation of Medical Device policy and Metrology, its significance on healthcare sector and the quality infrastructure of Medical devices. The contribution of CSIR, NPL in strengthening and supporting the medical device policy, as well as the establishment of medical device calibration facilities and the development of diagnostic devices through R & D are highlighted and discussed briefly. |
