End-to-end traceability

Whether you design, develop, produce or install medical devices, opting to follow the ISO 13485:2016 framework will provide confidence in your quality management approach, improve performance, increase speed to market – and certification will make your business more attractive to a global level.

Qualsys provides a complete software and support package for a validated medical device quality management system.

EQMS provides your entire organisation with a single source of truth for all processes and policies. Apply a risk based approach, effectively manage change, monitor staff competency and training records, control documentation, and implement a thorough auditing program.

Complex circle

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

Our software supports compliance to ISO 13485.

Embed 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.

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.

FDA 21 CFR Part 11 compliant electronic signatures and records

EQMS is compliant with FDA and EU medical device electronic signatures.

Instant reporting

Instant reporting makes it much easier to address areas of concern, risks and effectively manage change.

Medical companies using EQMS by Qualsys

pharmaceutical quality management software
Medical device manufacturers ISO 13485 DYSIS
Indivior medical device compliance
Vision RT medical device quality management
Synexus clinical trial management software
pharmaceutical quality control and assurance software and systems
Biotech quality management software
Pharma compliance management software
pharma management system
pharmaceutical qms software
pharma qms software
pharmaceutical quality management software systems

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, team, and wider business access to a customised view of your governance, risk and compliance performance.
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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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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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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.

Tell us how we can help you on your journey:

ISO 13485:2016 software FAQs

How does EQMS help me manage design history file?

The design history file  contains all product development documentation pertaining to a finished medical device. In EQMS, you can maintain a DHF for each type of device that you manufacture, you can demonstrate the device was developed in accordance with both the design plan and the requirements of this part, and reference all necessary documents.

Arrange your demonstration here

Is EQMS validated?

Iterations of EQMS have been validated to meet global regulations and standards. Qualsys provides a thorough validation service. Qualsys follow the GAMP 5 category 4 approach to computer systems validation. This approach is inline with European EMA and US FDA Regulations.

  • Fully managed, flexible validation support package from start to finish
  • Full documentation template suite for all systems validation requirements
  • Support throughout the process and afterwards with a dedicated validation team

Read our validation service procedure brochure

What medical device companies use EQMS for ISO 13485?

Around 40 percent of Qualsys customers are in the life science, pharmaceutical, clinical trial and medical device sectors. Qualsys is the preferred solution because we offer a mature quality management system which benefits the entire business – making quality best practice embedded everywhere. Every employee knows their roles and responsibilities, processes are fit for purpose, and leadership are able to effectively govern the organisation.

Browse our medical device case studies here

How do you manage EQMS upgrades and ongoing validation?

EQMS remains in a validated state throughout it’s lifecycle. This means no additional validation is required after the initial validation is completed – this includes subsequent upgrades, unless there is critical additional functionality required by future versions or the user requirements specification changes due to new business needs. Ongoing validation support with be discussed with you and tailored to meet your requirements during the procurement process.

Read more about our plans and packages

Latest insights

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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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ISO 13485:2016 clauses and how our software helps you comply
Organisations who design, develop, produce, or install medical device products or services often make a strategic decision to certify to ISO 13485:2016. ISO 13485 harmonises medical device regulatory requirements and provides a best practice framework for a medical device quality management system....
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ISO 13485:2016 7.3: Design controls for medical devices
Design controls are a set of policies and practices intended to ensure consistent translation of input requirements into a physical product that meets those requirements. Good design controls are important to: Reduce product risks Demonstrate your product is fit for purpose Align your organisation...
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