ISO 13485:2016

You need to demonstrate your products are fit for purpose, consistent and safe. The only way to achieve this is by having a robust quality management system which will enable you to effectively manage risk, control documentation and communicate with your employees.

For this reason, many medical device manufacturers use ISO 13485 to plan and manage their quality management system. The standard provides a framework to ensure you have a quality management system that works and as the standard harmonises many international regulatory requirements, it makes it much easier for you to trade internationally.

From document control to risk management, third-party product procurement to employee competence management, our software gives you everything you need to plan and manage a medical device quality management system which meets all ISO 13485 requirements.

Complex circle

Certify to ISO 13485 with our best practice software and implementation services

Our software supports compliance to ISO 13485.

Systematic risk-based thinking

Our software provides enables you to systematically identify, assess, manage and record risk.

Ensure your employees are fully competent

Integrated modules help you ensure your employees are competent and address any training gaps.

Validate your processes

Configurations of our software have been validated to demonstrate processes and our software is fit for even Class III medical device manufacturers.

Store records in a secure, incorruptible system

Our software provides you with unshakeable control over your documentation.

Control external provisions

Continuously monitor and re-evaluate supplier activities to ensure the product meets your business's requirements.

Instant reporting

Instant reporting makes it much easier to address areas of concern.

Software for an integrated medical device quality management system

Our software modules work well on their own or together.
Document control software
Document control software
Modern technology means we are bombarded with information. The challenge is making sure the right information is viewed by the right person at the right time. Document Manager by Qualsys provides a comprehensive and powerful solution for the distribution and control of all types of crucial documenta...
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Audit management software
Audit management software
Too many businesses hope that when an external auditor is examining their business they don’t uncover any issues. But this approach causes stress, encourages a reactive culture and exposes the business to high levels of risk. A regular and thorough internal auditing programme helps you identify an...
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Equipment maintenance software
Equipment maintenance software
Over 70% of organisations have no formal method for managing how equipment is used, maintained and eventually replaced, or for ensuring there’s a qualified person on-site to operate that equipment. Managing business equipment correctly is crucial if your organisation is to compete in the fast-pace...
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GRC dashboard
GRC dashboard
Give your leadership, employees and external providers simple and secure access to your governance, risk and compliance analytics.
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Accident & incident management software
Accident & incident management software
When an accident or incident occurs, it's important there is an accurate record of events to understand the root cause and prevent it from happening again. Use our accident and incident management software to properly record, communicate and identify trends to prevent it from happening again.
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Read our success stories

We’ve implemented hundreds of quality management systems for heavily-regulated businesses to ensure they meet Standards such as ISO 13485.

ISO 13485 toolkit

Find a range of materials, presentations and videos to help you meet the ISO 13485 requirements.

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Validation
Global pharmaceutical businesses, NHS trusts and other life-science businesses have been able to validate our software as compliant with the requirements of regulations such as GAMP 5, ISO 9001, ICH GCP E6 and FDA 21CFR Part 11, and electronic signature legislation such as the EU Electronic Signatur...
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Latest insights

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ISO 13485 overview
The UK has one of the largest medical device markets in the world, and it is forecast to grow by a culumative 16% by 2020.* Demand for medical devices is largely driven by innovation and an aging population. For organisations wishing to enter the market, one of the main challenges is navigating a co...
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ISO 13485 software validation process
When you're implementing an electronic medical device quality management system, your software validation plan is of the utmost importance. You'll need to ensure that your system is working and continues to work as required.
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