Medical devices · ISO 13485

ISO 13485 QMS software for medical device manufacturers

Controlled documents with full approval history, change control, CAPA, training records and audits, so the evidence a notified body or customer asks for is always one search away.

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Why medical device QMS needs stronger controls

ISO 13485:2016 expects more documented evidence than ISO 9001: documented procedures for most processes, records of competence and training, controlled changes with assessment of their effect, and a CAPA process with verification of effectiveness. Retention periods are tied to the lifetime of the device.

Paper and shared drives make this evidence slow to find and easy to break. A signature missing from a change record or a training record that cannot be located can turn into a major finding.

The Zefron QMS Portal keeps every document, change and approval with its history, links CAPA actions to their verification, and keeps training records as audit evidence. Because the portal runs on your own server, your design and production data stays under your control. If your products fall under specific regulations such as 21 CFR Part 11, we will work with your team on the validation you need.

Medical device features

Controlled documents

Procedures, work instructions and forms with approval history
Revisions with reason for change
Periodic review reminders
Retention per record type

Change control

Change requests with impact review
Department actions and digital sign-off
Linked to affected documents
Configurable numbering

CAPA

Structured problem solving with root cause
Actions with owners and due dates
Effectiveness check before closure
Trend by department

Training & audits

Training records as audit evidence
Internal and supplier audits
Findings with follow-up
Certificate expiry reminders

ISO 13485 requirements mapped to the portal

Selected clauses. Regulatory validation remains the responsibility of the manufacturer.

Requirement	How the portal supports it
4.2.4 Control of documents	Approval before issue, review and update, revision status, prevention of obsolete use.
4.2.5 Control of records	Records protected, retrievable, with retention and disposal defined per type.
6.2 Competence, training and awareness	Training records stored and linked to users and departments.
7.4 Purchasing / supplier control	Supplier audits, findings and approved supplier documents.
8.2.4 Internal audit	Audit plan, checklists, findings and follow-up in one place.
8.5.2 / 8.5.3 Corrective and preventive action	CAPA with root cause, actions, and verification of effectiveness.
Change control (4.1.4, 7.3.9)	Change requests with impact assessment and sign-off before implementation.

Live in three steps

Configure

We set up your sites, departments, standards, document levels, numbering and approval chains.

Migrate

Your existing procedures, work instructions, forms and records are moved into the portal with their current revision.

Train & go live

Administrators and users are trained online. Most organisations go live within two to four weeks.

Frequently asked questions

Is the portal validated for 21 CFR Part 11?

The portal provides audit trails, unique logins and approval records that support electronic records controls. Formal computer system validation for your intended use is done with your team; we provide the documentation and support it needs.

Can we keep records for the lifetime of the device?

Yes. Retention periods are set per record type, and records stay protected and retrievable until their disposal step.

Does it support supplier audits?

Yes. Supplier audits use the same audit plans, checklists and findings as internal audits.

Where is our data stored?

On your own server or private cloud. We do not store your documents on shared infrastructure.

Can we use it for ISO 9001 and ISO 14001 too?

Yes. Several standards can run in the same portal with shared users and departments.