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PCCP Scope Audit

Describe the device, the proposed change, the existing PCCP, and the modification driver. Get a scope assessment against each of the three required PCCP sections (Description of Modifications / Modification Protocol / Impact Assessment), a recommendation (fits / amend / new submission), and specific questions for regulatory affairs and clinical lead.

✓ Intended-use changes flagged as almost-never within PCCP scope✓ Cybersecurity + labeling + clinical evaluation implications addressed✓ Post-market-driven modifications linked to 21 CFR 803 obligations

Results in ~35 seconds · Saves ~5 days per change request

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