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.
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, SOPs, TMF, DHF.
Control external provisions
Continuously monitor and re-evaluate supplier activities to ensure the product meets your business's requirements.
Instant reporting makes it much easier to address areas of concern.
We’ve implemented hundreds of quality management systems for heavily-regulated businesses to ensure they meet Standards such as ISO 13485.
Find a range of materials, presentations and videos to help you meet the ISO 13485 requirements.