Addressing Critical Needs

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Behind Schedule

All manufacturers experience delays in completing HF projects, and a significant 70% of external HF service providers or consultancy firms encounter similar challenges.

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No Quality System

Half of HF service providers lack a quality system, show unawareness or have no plans to implement any kind of systematic approach for ensuring HF project quality.

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Failure Rate

According to FDA data, failure rates per HF submission type: 96.1% for Q-sub, 93.5% for PMA, and 89.5% for 510(k).

 

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