eQMS Medical Device

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eQMS Medical Device

Built-in compliance

Avoid error-prone manual tasks and any risks with compliance issues caused by human errors.

Single source of truth

All the information is in one place, from the requirements to realization and delivery to meet regulatory compliance.

Always audit ready

Produce audit reports in seconds, and provide evidence of electronic signatures with track and traceability across all your processes.

Ensure compliance with regulatory requirements for medical devices
eQMS Medical Device provides complete control over your medical device development, including design controls, multiple phases of manufacturing, and product safety management. It helps you meet ISO 13485, FDA CFR 21 Part 820 regulation, , and EU Directives. This solution ensures that the range of employee roles and responsibilities complies with your medical device product lifecycle.

eQMS Audit Module

The modern way of managing audits – With full electronic traceability, automatically generated audit reports, and a complete overview of

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Automate processes – in a compliant way
eQMS Medical Device is a solution that streamlines manual processes. It automates approval processes and electronic signatures, eliminating manual tasks such as sending forms back and forth between teams. With eQMS Medical Device, you can achieve regulatory compliance in a fraction of the time.
Case Study: Serán Bioscience, LLC
Optimizing Document Management at Serán Bioscience with Novunex eQMS Document Control
Effective validation of software compliance
Validation-ready documentation to ensure compliance with 21 CFR Part 11 and other FDA requirements: Built upon a well-documented process engine, the effort to validate the software utilizes lean principles. Novunex eQMS Medical Device has built-in mechanisms to support efficient revalidation as part of the change control process.

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