ISO 13485 QMS Software

ISO 13485 compliant QMS software that helps you maintain a compliant quality management system (QMS) according to ISO 13485 standard.

SimplerQMS Document Control Interface - Procedure List

ISO 13485 compliant QMS software designed for medical devices

ISO 13485 is a regulatory standard that specifies quality management system requirements that can demonstrate an organization’s ability to consistently provide compliant medical devices and related services. ISO 13485 Software then offers a solution that complies with the ISO 13485 standard and helps you simplify your QA/RA management.

The main benefit of ISO 13485 QMS software for your firm

The development of a medical device involves continuous updates, changes, and revisions that are often aimed at one or more components of the device. SimplerQMS provides ISO 13485 compliant software that is equipped with features to ease medical device development. Efficient change management workflows combined with intuitive design controls are the tools that could help you significantly reduce your time to market.

Approved Document
Integrated QMS Software

Connect all your quality processes

With the ISO 13485 software, the documents in your QMS can be interlinked so that you can experience even smoother workflows. Link your DHF, DMR, TF to specific products and easily observe how changes affect other files in your system. With SimplerQMS you will be able to:


Have a fully traceable system with no missing files


Identify root causes and recognize the underlying problems


Manage your QA/RA documentation from any location


Get automatic notifications for your tasks, calibration, training activities, etc.


Decrease the chance of human error and seamlessly improve efficiency

Streamline your design control management

SimplerQMS design control module allows you to be better prepared for audits with easily searchable documentation gathered in one place. The functions of documents linking or DHF dashboards will let you easily demonstrate the structure of your system during an audit while the search feature will allow you to locate files within seconds. Take a look at the DEMO for a more practical example.

SimplerQMS Technology Platform

Utilize trusted technology platform

The SimplerQMS ISO 13485 software uses the M-Files document management system as a core of its technology. M-files is a company with 20+ years of experience and more than 5000 international customers. Thanks to this aspect, we can offer a system that is fully integrated with Microsoft office. This means that you won’t need to constantly download and upload documents to the ISO 13485 Software to edit them. Just use Microsoft Office to make changes and then save them with 1 click. It’s that simple.

Automate document control activities

The SimplerQMS document control module allows you to enforce the usage of standardized forms. Our ISO 13485 compliant QMS software integrates with familiar Microsoft Office applications – Excel, Word, PowerPoint. You can easily notify employees about pending tasks, signature requests, and other activities. Lastly, the documents are automatically versioned and numbered in the system.

Microsoft Office Interface
Time Resources

Fast implementation, pre-validated software

The SimplerQMS ISO 13485 quality management system software is pre-validated. This means that you can start using your new eQMS right after the implementation with no additional costs for validation. Additionally, we worked hard to develop a smooth implementation process with no bottlenecks so that you don’t have to allocate more time and resources to the implementation than necessary. Currently, our implementation process takes on average 5-6 weeks.

Ensure regulatory compliance

SimplerQMS complies with ISO 13485, FDA 21 CFR Part 11, GxP, GMP, FDA 21 CFR Part 820, and EU MDR. We built the system so that it can reliably comply with different regulatory standards. For that reason, we stand by it during audits as well. During your audits, we take full regulatory responsibility for the functioning and validation of the system. If your auditor has questions regarding the SimplerQMS software, we will be happy to answer them.

Medical Device Regulatory Compliance
Document Change Control

Streamline your change management processes

Enjoy full traceability within the SimplerQMS ISO 13485 compliant software. You can easily determine which employee made what change at what time as well as the impact of the change. That way you can recognize non-compliant behaviors early on and prevent them from escalating. Furthermore, when comparing paper-based QMS to SimplerQMS, our customers report a 50% reduction of time spent on change management.

What customers achieve with SimplerQMS

Utilize proven technology

SimplerQMS is built on Microsoft & M-Files Technology which serves over 5,000 customers worldwide.


Pass audit more easily

Access needed documentation and present it to the auditor with a couple of clicks from anywhere in the world.


Gain a high level of traceability

Gain cross-functional visibility and trace back to the root cause of each nonconformance.

“It’s very flexible, smooth, and easy to use. Documents no longer get lost and the whole history of all products is accessible for anyone at any time.”

Christian Schärfe Thomsen

Project Manager, Cortex

Ready to learn more?

To learn how you can make the most of SimplerQMS, request a free, personalized demo presentation.

SimplerQMS Demo Interface