“The notified body asked where this claim comes from, and I'm digging.”
Defend every claim in your file.
The problem
- Every CER update means redoing the literature search and defending it to the notified body.
- Post-market data from complaints, vigilance and literature lives in five places.
- I must show where every claim in the technical file traces to evidence.
With INDAGO
- A reproducible literature-search appendix for each CER update.
- Fast, traceable answers to notified-body deficiency questions.
- PMS evidence assembled in one local index.
Real capture · Research asks who you are before it shows a single screen.INDAGO Research 0.7.9 · 65,303 Wikipedia articles
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INDAGO Research
A reproducible literature-search appendix for each CER update.
Why your tools fall short.
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Quality-management software stores files but cannot search across them by meaning or cite pages.
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Literature databases don't produce a reproducible, documented search trail by themselves.
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Cloud AI is a confidentiality risk for design and trial data.
MDRRegulation (EU) 2017/745: Art. 61, 83–86, Annex XIV, technical documentation per Annex II/III
ISO 13485Documented-evidence expectations, together with ISO 14971
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Your documents stay on your Mac.
macOS · Apple silicon · Signed and notarised