Medical Device Single Audit Program (MDSAP) | HCL Whitepaper

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Medical devices industry is highly regulated with stringent controls exerted on the design, development, manufacturing and marketing of devices to ensure safety, performance and quality in public health sector. Manufacturers are bound to undergo audits conducted by various regulatory agencies, depending on the markets where the devices are placed and the intended use of the device. In addition, manufacturers are expected to adhere to the requirements specified by the particular regulatory authority of a country or region and need to provide evidence of compliance towards the applicable regulations either through an audit/inspection or through precise technical documentation. A manufacturer has to undergo various audits to ensure its compliance to requirements, more or less similar, put forth by various regulatory authorities. A fair amount of time and resources are spent by both the manufacturers and the auditing organizations/regulatory authorities on these various audits.

Medical Device Single Audit Program (MDSAP) is initiated with an objective to develop a global approach to audit and monitor the medical devices manufacturers, which can ultimately improve the safety of devices as well as improve the oversight on manufacturers on an international scale. MDSAP enables the manufacturer to have a consolidated audit for the requirements of the Regulatory authorities (RA) participating in this audit program, instead of having separate audits for each regulatory authority.