Document Control
ISO 13485 §4.2
Enforced revision history, approval workflows and effective dates. Only the current approved version circulates; every superseded one stays retrievable.
Why devices
A Notified Body audit is a records audit
The technical file proves the device. The quality system proves you can keep making it. What the auditor samples is the record: which revision was in force, who was trained on it, what you did about the last deviation and whether the CAPA worked.
ISO 13485 §4.2 and §6.2
Controlled documents with enforced states, and a training matrix kept true by document effectivity rather than by hand.
Harmonised standards
The Officer watches the Commission’s harmonised lists and the UK designated lists, so an edition change is a finding, not a surprise.
Your own ISO text
Clause-level citations against ISO 13485 use your verified licensed copy, scoped to your workspace, never a shared one.
Scoped auditor access
Give the Notified Body or a customer auditor read-only, time-limited access to exactly the records they need.
Posture
Where we stand on the standards that matter here
| Standard | What it requires | Our status |
|---|---|---|
| 21 CFR Part 11 | Electronic records and electronic signatures | Self-attested |
| GDPR | Lawful processing, minimisation, right to erasure | Self-attested |
| ISO 13485 | Quality management for medical devices | Controls in place, validation in progress |
| ISO 9001 | General quality management framework | Controls in place, validation in progress |
Notes
- Statuses are stated as they are. Self-attested means our own attestation, not a third-party certificate.
What you get
The five modules, as sold today
Training Management
ISO 13485 §6.2
Role-based matrices, assignment straight from a controlled document, quizzes, and requalification tracked per person.
Deviation Management
EU GMP Ch. 1
Logged, risk-assessed, investigated and dispositioned, with a controlled path into CAPA when the investigation warrants one.
CAPA
ISO 13485 §8.5
Owned action items, due dates, and an effectiveness review that must complete before closure.
Internal Audits
ISO 13485 §8.2.4
Programme planning, checklists, findings and closure evidence. Findings raise CAPAs directly; external auditors get scoped access.