Life sciences

From the law in force to the finished SOP.

Sina links your SOPs and study documents with MDR, IVDR and EHDS. She shows which obligations apply and what is changing – every statement with its source.

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The problem

The obligation is in the regulation – its implementation is in your SOP.

MDR, IVDR, guidelines and your study documents: for every release you pull it all together by hand. And in the audit, what counts is not what sounds plausible, but what is evidenced.

The question

You ask Sina – in a single sentence.

Instead of wading through regulations, you simply ask. Sina shows what is being checked – step by step, across all sources.

The evidenced answer

Every obligation comes with its source.

Every statement names the article and the source. Whatever cannot be evidenced, Sina flags as open.

The next step

Sina prepares – QA approves.

Sina prepares the next step. It is only submitted once QA approves it.

Hello, I'm Sina – your AI agent for life sciences. I keep an eye on your QMS and the law in force, and I get in touch when something changes.
I noticed three points today that affect your Class IIa product:
Signals · today
SharePointSOP-12 “Conformity assessment”
c:node GraphMDR 2017/745 · Annex IX
c:node GraphEvidence requirements tightened from 10 Jan 2028
@Sina, which obligations from MDR and IVDR apply to our Class IIa product – and what is changing right now?
I'm checking all sources:
  • Read SOP-12 and study documents
  • Determined product class against MDR Annex VIII
  • Matched the conformity route per MDR Annex IX
  • Checked UDI and registration obligations
  • Applied the deadlines from the current guideline
Conformity assessment per Annex IX – with one open point.
  • Class IIa confirmed: conformity assessment per MDR Annex IX applies
  • UDI obligation and registration in EUDAMED required
  • From 10 Jan 2028, tightened evidence requirements – adjust SOP-12 accordingly
  • Product-specific special rule from your notified body not on file – clarify before submission
MDR 2017/745 · Art. 52MDR · Annex IXSOP-12 pp. 2–4Notified body guideline
I've prepared the next step:
Draft · SOP-12 update + query to notified body
Updating SOP-12 to the evidence requirements applying from 10 Jan 2028, plus a query to the notified body about the product-specific special rule. The case has been opened for QA approval.
ApproveEditNothing goes out without approval

Example case with sample data · legal bases are real · not legal advice.

Sales booklet

Life sciences — the whole picture as a PDF.

Use cases, packages, roll-out and the business case behind it — compact, ready to take with you and pass on.

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Your next step.

See c:node on your own case – or check where it runs and how it keeps you secure.

See a demo on your case

Give c:node a short test run with a real question from your everyday work – evidenced, step by step.

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See security

Where c:node runs, how you approve and what is evidenced – EU cloud Frankfurt or your own server.

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FAQ

Frequently asked questions

Does c:node replace our QA?

No. c:node prepares the review – it links your SOPs and study documents with MDR, IVDR, EHDS and the guidelines and evidences every obligation with its source. It is only submitted after your approval by QA.

Where do the sources come from?

From your own documents and the c:node Graph – MDR, IVDR, EHDS and the guidelines in force. Every statement carries the article and source; where there is none, c:node says so openly.

Where does our data run?

In the EU cloud Frankfurt or on your own server up to air-gapped. Your study and product data does not leave the EU or your premises – and we do not train on your data.

Is this audit-proof for audits and the notified body?

Yes. c:node stores the source and legal basis for every obligation and produces an audit trail that you can show in an audit or to the notified body – without exposing the internals of the model.