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