Audit software for the medical device industry
In a medical device QMS, evidence is what counts: notified bodies expect a documented audit procedure, objective auditors and fully traceable corrective actions. IMS-Audit Cloud keeps audits, CAPA, controlled documents and management review together in one system – with field-level change tracking.
The standards that shape audits in this industry
Documented audit process, CAPA with effectiveness checks, records
Standard page →Often certified in parallel – internal audits under both standards in one programme
Standard page →Information security for connected devices and patient data
Standard page →Ready-made question catalogues for these standards are sold separately – see question catalogues.
Typical audit requirements in this industry
- Documented procedure for internal audits with records that remain traceable years later
- CAPA: root-cause analysis, corrective and preventive actions with documented effectiveness checks
- Controlled documents with approval workflow, revision history and four-eyes principle
- Supplier monitoring and audits for critical suppliers
- Management review with inputs from audits, complaints and CAPA
Note: this overview describes typical requirements from practice and replaces neither the text of the standard nor customer-specific requirements.
Medical devices: audits with IMS-Audit Cloud
CAPA with effectiveness checks
Corrective and preventive actions with owners, deadlines, escalation and documented effectiveness.
Learn more →Document control
Draft → Approved → Archived, revision history with person and timestamp, optional four-eyes principle, review dates with reminders.
Learn more →Documented audit process
All audit data centrally on the audit, findings recorded immediately, field-level change tracking – traceable and audit-proof.
Learn more →Roles, permissions, 2FA
Granular permissions per person, optional two-factor authentication that can be made mandatory, a separate database per company.
Learn more →Management review
Audits, actions, complaints and risks flow automatically into the review as data blocks; audit-proof finalisation, PDF minutes.
Learn more →Supplier audits
Audit critical suppliers with uniform catalogues, actions handled at the supplier via restricted logins in IMS-Audit Cloud.
Learn more →Audit software for medical devices
Is the change history traceable for notified bodies?
Yes. IMS-Audit Cloud logs changes at field level – who changed what and when. In document control, every status change carries a person and timestamp, and finalised management reviews are frozen in an audit-proof way.
How is the effectiveness of CAPA documented?
Directly on the individual action: root-cause analysis, corrective action and, later, the effectiveness check. The actions cockpit shows status and due dates; overdue actions escalate by e-mail.
Is there a question catalogue for ISO 13485?
Yes, a ready-made ISO 13485 catalogue is sold separately – please contact us. You can create your own catalogues, for example for product-specific inspections, at any time free of charge or import them via Excel.
Audit software that fits your industry — see it for yourself.
All modules included, no set-up fee. In a personal meeting we show you the cloud using your own topics.