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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 Scalable
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.
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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
Some of our innovative medical device customers
Perfuze
Innovative Medical Technology to treat Acute Ischemic Stroke
Rockfield Medical
Innovative Feed Delivery Systems
Aurigen Medical
An Electrophysiology and Structural Heart Company
Bluedrop Medical
Reducing the Burden of Diabetic Foot Disease
Loci Orthopaedics
Innovative Orthopaedic Solutions
