Healthcare
Medical devices
Regulated products, strict approvals – advisories with a complete audit trail.
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documented approvals
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faster audit preparation
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unreviewed publications
The challenge
MDR, CRA and hospitals as customers: every publication needs a documented approval, and hospital IT expects reliable, signed information.
The solution with Secvisory
Four-eyes approval mirrors the QM process, every version is archived immutably and the audit log can be exported at any time.
Compliance you can audit
In medical technology, traceability is everything. Secvisory logs every change, every approval and every publication.
- Four-eyes principle with separate roles for authors and reviewers
- TLP:AMBER for advance information to selected hospitals
- Immutable versions – every change creates a new advisory version
- Export of the audit log for auditors and notified bodies
“The audit log cut our last inspection from three days to one afternoon.”
Regulatory Affairs Manager, medical device manufacturer (example)
