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.
Control policies, documents and records for your medical device quality management system.
Ensure staff are competent and you always have records to demonstrate due diligence.
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.
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.
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.
Don’t just take our word for it. See all the great things our customers have achieved using our software.
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.
- Maximise return on investment by providing a business management system everyone can interact with at some level
- Scalable licensing, so you’re not limited when your business grows
- Dedicated GAMP 5 CSV team