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Manufacturers are encouraged to implement robust quality management systems (QMS) adhering
to international standards like ISO 13485. Th is fosters elevated product quality and patient safety.
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MDSAP emphasizes a risk-centric approach to auditing, allowing regulatory authorities to concentrate
on higher-risk areas within a manufacturer’s QMS.
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Th e program cultivates communication and collaboration between regulatory authorities
and manufacturers, fostering a more profound understanding of regulatory expectations
and requisites.
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MDSAP contributes to the harmonization of regulatory requirements across participating
countries, diminishing disparities and simplifying manufacturers’ navigation of international
markets.
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Th rough the audit process, manufacturers receive constructive feedback on their quality
management systems, providing an opportunity for refi nement and ultimately yielding higher
quality products.
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Manufacturers aligning with MDSAP requirements may gain a competitive edge by exemplifying a
dedication to quality and compliance on a global scale.
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MDSAP off ers a meticulously standardized system that defi nes clear expectations between manufacturers and regulatory
authorities regarding audit procedures, duration, nonconformance grading, and ensuing actions.
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Th e MDSAP Audit Approach Document stands as a comprehensive guide for auditors and participating manufacturers. It
ensures audits are conducted uniformly, adhering to established standards and procedures. It categorizes processes within the
QMS and delineates specifi c tasks for assessing conformity.
For further transparency, this document is publicly accessible through the FDA website’s MDSAP Audit Procedures and
Forms page. Th is empowers manufacturers and auditors alike with precise insights into what should be reviewed and assessed
during an MDSAP audit.