ISO 13485 software

Ensure the quality, customer satisfaction and safety of medical devices with ISO 13485 software.

ISO 13485 logo

What is ISO 13485?

ISO 13485 is the international standard for implementing a quality management system for medical device companies. It allows organisations to easily demonstrate that their products and services are up to standard and meet customer and regulatory expectations. It’s applicable for organisations across all stages of the medical device supply chain.


The benefits of gaining ISO 13485 accreditation

The purpose of ISO 13485 is to provide a best practice framework which is standardised across the medical device industry. It improves performance, communication and speed to market. By enabling you to produce reliable, high quality medical devices, accreditation with this standard also gives confidence to your suppliers, customers and patients.

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Why ISO 13485 software?

Using dedicated software to meet the requirements of ISO 13485 allows you to approach the standard as a whole, rather than looking at the different clauses separately. It makes it easier to adopt and manage the requirements.

Report on any system activity quickly and easily

From outstanding document reviews to audit findings, give yourself confident control of your medical device quality environment.

Embed a risk-based approach into your products’ lifecycle

Record and treat risks, target non-conformances with dedicated workflows, and build a paperless audit and inspection programme to get under the skin of your operation.

Experience powerful data management

Pull your medical device quality data from siloed and paper-based systems into a single, centralised source of truth accessible from anywhere with an internet connection.

Document compliance activities

Track ISO 13485 compliance clause by clause, from management responsibility to resource management and product realisation.

Gain complete control of your product lifecycle

Get things done faster, measure and analyse your quality approach, and take smarter data-driven action supported by in-depth system reporting.



Refine and improve process

Use our visual workflow engine to map your quality and compliance processes into your digital QMS. Push actions along workflows to manage CAPA plans, out-of-specification investigations, customer feedback, and any kind of business process.

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Document management made simple

Securely store and manage any kind of business documentation. This could range from design history files and technical drawings, to target product profiles and quality manuals, with built-in version control and approval processes.

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Audit in real-time

Build and control a digital paperless audit programme with bespoke checklists and templates to pinpoint risks and harness opportunities. Perform targeted audits across your medical device lifecycle, from pre-clinical testing to post-market vigilance.

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Putting risk front and centre

Build a living risk register. Assess, score and manage your risks to control your risk environment and embed a risk-based approach into your medical device QMS.

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Keep training records up to date

Prove your staff are appropriately trained and competent for their roles with a living training record library. Schedule, record and give feedback on training, and categorise training by departments, roles and even standard-specific requirements.

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Interested parties

Manage your relationships

Clause 7.4 of ISO 13485 places emphasis on close control of your third parties. Maintain a comprehensive record of your interested party relationships, from suppliers to customers and regulators, and associate tasks, key documentation, issues and other information to them.

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See our software in action

Learn more about how our software can support your ISO 13485 compliance. 

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