COMPLY, CREATE,

ACCELERATE

What we do

End-to-end Quality Management

The CompanionQMS platform provides an end-to-end, user-friendly quality management solution, designed specifically for the regulated medical device industry.

Standards Compliant for Small to Medium Enterprises

CompanionQMS addresses the needs of small and medium enterprises while complying with rigorous security standards including ISO 27001 and the electronic record and signature requirements of 21 CFR Part 11.

Accessible, Secure and Scaleable

Designed using the highly configurable Microsoft SharePoint platform CompanionQMS is a cloud-enabled, secure, and scalable solution, delivering superior document management, intelligent workflows and reporting tools in one single interface.

Streamlined to Simplify Regulatory Journey

With CompanionQMS, product development and regulatory compliance is streamlined to simplify the regulatory journey and shorten time to market for medical devices.

Key Benefits

User-Friendly and Quickly Deployed

Lean, intelligent workflows, incorporating FDA, ISO and GxP best practices

Flexibility in Design

Facilitate remote working with a secure private cloud service

Reduce Regulatory Risks

21 CFR Part 11 compliant Electronic Signatures

Lower risk for potential investors and acquirers

Comply with Security Standards including ISO 27001

Reduce time to market for your medical device

Contact us to learn more about Companion QMS

“Implementing Companion QMS has┬ásaved us a significant amount of time compared to a paper-based system; it simplifies quality management allowing us to focus on product development.”

CEO, Dr.Brendan Boland
LOCI Orthopaedics, Galway Ireland

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