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Repeat Nonconformity:
Nonconformities previously identifi ed within the last 3 years are escalated due to the increased risk they pose, indicating
insuffi cient corrective action.
•
Absence of a Procedure:
Th e absence of a documented process or procedure signifi cantly impacts consistency and eff ective implementation,
warranting escalated grading.
•
Release of a Nonconforming Medical Device:
Nonconformities leading to the release of a nonconforming medical device into the market directly signify a QMS failure,
resulting in higher-risk grading.
Th ese factors collectively contribute to the grading of nonconformities. Starting with the impact, indirect impact initiates
at a grade of 1, while direct impact begins at 3. Subsequently, any true escalation factors (repeat nonconformity, absence of
a procedure, or release of a nonconforming medical device) increase the fi nding grade. While a grade of 6 is theoretically
attainable, the highest grade assigned remains a critical 5. Th is stringent grading system ensures thorough assessment and
prompt reporting of critical fi ndings to uphold the integrity and safety of medical devices.
In conclusion, the Medical Device Single Audit Program (MDSAP) stands as a transformative initiative, streamlining
regulatory processes for medical device manufacturers worldwide. By enabling a unifi ed approach to audits and assessments,
MDSAP not only empowers manufacturers to meet the diverse requirements of participating countries but also fosters a
culture of continuous improvement and excellence. Th rough standardized procedures, transparent expectations, and stringent
grading, MDSAP ensures the highest standards of quality and safety in the production of medical devices. Th is collaborative
eff ort between manufacturers and regulatory authorities marks a signifi cant milestone in the global healthcare industry,
ultimately benefi ting patients and providers alike. As MDSAP continues to evolve, its impact on the industry is poised to be
both profound and enduring.