MDR Art. 10(9) · ISO 13485Live in the platform

Quality Management System

Thirteen Article 10(9) obligations, each backed by reviewed evidence from your own controlled documents, released as a sealed Evidence Appendix.

See it in a demo All workflows

The Article 10(9) evidence matrix in Complya: thirteen obligation rows with review statuses, showing 11 of 13 accepted and the appendix not yet issuable — The Article 10(9) evidence matrix, mid-review: the appendix can only issue at 13 of 13 accepted. Synthetic example data.

STEP 1

Provide your QMS documents

Upload procedures, SOPs and quality records. Complya classifies them as controlled source documents with declared status.

STEP 2

AI maps evidence to the 13 obligations

Each Article 10(9) requirement is matched with candidate evidence from your own documents, cited to source.

STEP 3

Expert review releases the appendix

A credentialed expert reviews each row. Only at 13 of 13 accepted can the Evidence Appendix issue, sealed and tamper-evident.

What the workflow does

As shipped. Every line below is live in the platform today.

A 13-row evidence matrix covering every Article 10(9) obligation, from regulatory-compliance procedures to CAPA and internal audit.

Manufacturer profile facts proposed by AI from your uploads and approved row by row, never assumed.

Controlled source documents with declared status and full supersession history.

Evidence reviewed and accepted per requirement; the appendix can only issue at strictly 13 of 13 accepted.

Issued appendix revisions are immutable and content-addressed: any change to the underlying evidence is visible, never silent.

Complya's internal maker-checker gate on its own regulatory content: one credentialed expert proposes, a different expert countersigns, enforced in the database. This is Complya's quality control, not ISO 13485 certification of your QMS.

THE SAME TRUST LAYER AS EVERY COMPLYA WORKFLOW

Sealed, not saved

Reviewed documents freeze as immutable revisions. A content-addressed seal binds the text to its inputs and every approved resolution.

Append-only history

Decision history cannot be edited from the application; corrections append as new records, never overwrite.

Grounded drafting

AI citations are verified verbatim against the cited source. A quote that cannot be located is dropped, never kept.

See it on your own device. Thirty minutes, no slides.

Book a demo All workflows