Software for ISO 13485

ISO 13485, without folders or surprises

Design control, validations, batch traceability and post-market surveillance, with the evidence your notified body asks for.

What it is and which edition applies

ISO 13485 is the quality management system standard for medical devices. Unlike ISO 9001 it does not follow Annex SL and does not centre on continual improvement: it is built around regulatory compliance and the maintenance of effective processes, with specific demands on the design file, process validation, batch traceability and unique device identification. In the European Union it sits alongside Regulation (EU) 2017/745 on medical devices.

Content reviewed on 25 August 2026

Current edition: ISO 13485:2016 Third edition, published March 2016
EU regulation: Regulation (EU) 2017/745 (MDR) Applicable since 26 May 2021
In vitro diagnostics: Regulation (EU) 2017/746 (IVDR) Applicable since 26 May 2022
Risk management: ISO 14971:2019 Reference standard for product risk analysis
Unique identification: UDI system Required by the MDR for supply-chain traceability

Document control

Versions, approvals and distribution with read receipts.

Connected to your document cloud

Publish and version documents by connecting to OneDrive, Google Drive or SharePoint, without duplicating folders.

Audits

Annual program, checklists per standard, findings linked to actions.

Non-conformities

Root cause, action, owner, deadline and effectiveness check.

KPIs

Process objectives fed with real operating data.

Legal requirements

A register of legal and other requirements, with validity and compliance evaluation per standard.

Corrective actions

Root cause, action, owner, deadline and effectiveness check, all linked to the nonconformity.

Improvement actions

Improvement opportunities with an owner and tracking, beyond just fixing what already failed.

Management review

A pre-built report with indicators, audits and nonconformities, ready for the meeting.

Batch traceability and UDI

Unique device identification across the whole chain.

Post-market surveillance

Complaints and surveillance with evidence ready for the notified body.

Process validation

Processes and equipment validated with protocol and validation report.

Critical suppliers

Critical suppliers approved and reassessed according to component risk.

Requirements covered

What it solves for ISO 13485

Design and development file
Process and equipment validation
Batch traceability and UDI
Complaint handling and surveillance
Critical supplier control
Risk management under ISO 14971

Standards covered

Pick your standard and see what it solves

GMP+ Animal feed safety Food industry · animal feed IATF 16949 Automotive Automotive SQAS2022 Chemical and logistics assessment Quality · chemical and logistics ISO 19600 Compliance management systems Compliance · guidance ISO 37301 Compliance management systems Compliance ISO 22716 Cosmetics manufacturing Quality · cosmetics GDPR Data protection Legal · data protection ISO 14001 Environmental management Environment SGE 21 Ethical and responsible management Social responsibility IFS Food Food safety Food industry FSSC 22000 Food safety management system Food industry BRCGS Global food standard Food industry ISO 14064 Greenhouse gases Environment · carbon footprint HACCP Hazard analysis and critical control points Food industry ISO 27001 Information security Cybersecurity ISO 20000 IT service management Quality · IT services ISO 13485 Medical devices Healthcare ISO 15189 Medical laboratories Quality · healthcare ENS National Security Framework Security · public sector UNE 73401 Nuclear quality assurance Quality · nuclear ISO 45001 Occupational health and safety Health & safety ISO 9001 Quality management Quality · every sector ISO 26000:2010 Social responsibility Social responsibility · guidance Sustainability Sustainability management ESG UNE 19602 Tax compliance Compliance · tax ISO 17025 Testing and calibration laboratories Quality · laboratories

Frequently asked questions

What people ask us before getting started

Which edition of the standard is current?

The edition in force is ISO 13485:2016. When the issuing body publishes a new one, a transition period opens; once it closes, certificates issued against the previous edition stop being valid.

Does this work if we are already certified?

Yes. Your existing system — processes, documents, records, audit history — is loaded in and kept alive from day one. Nothing needs redesigning and the certification cycle does not restart.

Will the auditor accept digital records?

Yes, provided they are traceable, controlled and able to show who did what and when. No standard requires paper; every standard requires reliable evidence, and a properly controlled electronic record provides it better than a folder.

Can it be combined with other standards?

Yes, and that is the sensible route. The common Annex SL structure lets a single integrated system share the process map, document control, internal audits, nonconformities and indicators between ISO 13485 and the rest, leaving only the standard-specific parts separate.

How long does it take to be ready for an audit?

It depends on the starting point. An organisation already working with written procedures is usually ready in two or three months; one starting from scratch needs longer. The bottleneck is rarely the tool — it is the availability of the people who know the processes.

What happens to the documentation we already have?

It is migrated. Existing procedures, forms and records are loaded with their version and approver, so the history is not lost and the system starts with the memory the organisation already had.

Can the auditor look directly at the system?

Yes. They are given read-only access with a defined scope and an expiry date. It is more comfortable for both sides than preparing a folder of screenshots and exports.

What is the difference between a major and a minor nonconformity?

A major one compromises the system's ability to meet a requirement — a required process missing altogether, systematic failure, or a failure affecting the product — and usually blocks certification until it is closed. A minor one is a specific lapse resolved with an action plan.

Are the indicators calculated automatically?

Yes, from the data the processes themselves generate. That is the difference between a dashboard that reflects what is happening and a spreadsheet somebody fills in the week before the management review.

Does it work across several sites or legal entities?

Yes. The model is multi-company and multi-site: what makes sense to share is shared, and what belongs to each location stays separate — including the certificate scope where it differs.

Get ready for your ISO 13485

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Keep exploring

Sources

Where each figure comes from

References to the official text in force. If a standard is revised, this page is updated and the review date says so.

ISO 13485:2016 — Medical devices. Quality management systems ISO · March 2016
Regulation (EU) 2017/745 on medical devices EUR-Lex · 5 April 2017
ISO 14971:2019 — Application of risk management to medical devices ISO · 2019 ed.

Software for ISO 13485 — Medical devices

Kimobox is a software for ISO 13485 that digitizes the requirements of the standard: design and development file, process and equipment validation, batch traceability and udi, complaint handling and surveillance, with full traceability and evidence ready for the auditor.

The platform lets you run an integrated management system that combines ISO 13485 with other ISO standards and sector protocols, sharing the process map, document control, internal audits, non-conformities and KPIs.