Robust quality management systems

You need to produce products that are safe and fit for purpose. To do this, you need employees who know what is expected of them, processes that work, and evidence that the processes have been implemented.

EQMS is designed to give you complete control and visibility over all of your business processes.

Complex circle

The most feature-rich medical device quality management software

Agile, risk-based approach to medical device quality management

Document control

Control policies, documents and records for your medical device quality management system.

Training management

Ensure staff are competent and you always have records to demonstrate due diligence.

Risk management

Actively monitor, identify, assess and treat emerging risks applying your frameworks.

Audit and inspection control

Implement an proactive audit and inspection program to ensure operational and strategic processes are fit for purpose.

CAPA enforced

Raise and enforce corrective and preventive action workflows when an issue is raised. Set completion deadlines and

15+ embedded compliance features

All the compliance tools, such as e-Signatures, workflows and audit trails, are working in the background to give you peace of mind.

Modules for medical device quality management systems

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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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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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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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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Supplier management software
Supplier management software
Qualsys's supplier compliance management software provides you with all the controls you need to treat external providers as an extension of your business. Deliver unshakeable governance, risk and compliance controls, understand supply chain risks, and extend quality best practice to your suppliers....
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Want to learn more about using our medical device quality management software? Schedule a 15-minute discovery call

Read our validation brochure

Learn about our five-phased approach to managing computer systems validation, and how we help you to comply with regulations and Standards such as ISO 13485:2016, GAMP 5, ICH GCP E6, FDA 21 CFR Part 11, and the EU Electronic signatures directive.

Life science and medical device case study booklet

Don’t just take our word for it. See all the great things our customers have achieved using our software.

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ISO 13485:2016 7.3: Design controls for medical devices
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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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Medical device QMS FAQs

What is medical device QMS software?

Medical device quality management system software provides you with a suite of tools to effectively manage governance, risk and compliance.

Throughout the device lifecycle, processes are incredibly iterative. It’s important for regulatory and quality purposes that you can demonstrate these processes are fit for purpose and prevent patient risk.

Within the Qualsys medical device quality management system software, you can do everything from manage design controls, history files, traceability, risk, evidence compliance, staff competence, and much more.

How many medical device quality management software systems has Qualsys implemented?

Approximately 40 percent of Qualsys’ customers are in the life science industry, including pharmaceutical, clinical trial and medical device sectors.

Qualsys provides you with a dedicated team who have experience implementing medical device quality management systems for large and small enterprises.

The Qualsys team have undergone GAMP 5 CSV training and run internal learning workshops to share best practices and improve value for our customers.

How does Qualsys compare to other medical device qms software providers?

While Greenlight Guru, Qualio, qmswrapper and several other providers focus solely on medical device quality management software, many medical device companies opt for EQMS by Qualsys because it has been developed in partnership with global leading businesses spanning multiple industries, for a variety of applications. EQMS by Qualsys makes an impact on the entire business. It’s not just a compliance tool for the quality team. It’s an enterprise business management system with all the compliance features working seamlessly in the background, providing significant time and cost saving return on investment.

It’s completely up to you which option you feel is best for your business.

Here are some of our case studies

Why Qualsys:

  1. Maximise return on investment by providing a business management system everyone can interact with at some level
  2. Scalable licensing, so you’re not limited when your business grows
  3. Dedicated GAMP 5 CSV team


Business Intelligence dashboard by Qualsys