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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 scopeCybersecurity + labeling + clinical evaluation implications addressedPost-market-driven modifications linked to 21 CFR 803 obligations

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

Common questions

Does this tool work with ChatGPT?

The tool itself runs on Claude (Anthropic) right here on the page — you don't need any AI subscription to use it. Everything it generates is plain text, so you can paste the output into ChatGPT, a document, or an email and keep working there. If you mainly work in ChatGPT, you can also reuse your inputs there to refine further.

What AI model powers this tool and the example output?

Claude, Anthropic's AI. The example outputs shown on tool pages were generated with Claude.

Do the paid prompt packs work with ChatGPT?

Yes — the packs are written and tested for Claude, and every pack includes a portable prompts-only set that works in ChatGPT and Gemini (copy and paste, occasionally with a minor tweak). The Cowork plugin editions specifically require a paid Claude plan.

Claude is a product of Anthropic. The AI Career Lab is not affiliated with Anthropic or OpenAI.

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