WHY YOU CAN TRUST US
1
Our manufacturing sites hold BS EN ISO 13485:2016 certification and are FDA Registered facilities (Facility Nos. 3007125292 & 3014255023)
2
RUA Medical has the ethos of building in robust quality control early in the design phase of every single one of our projects.
3
Our Device History Records are designed to provide full product traceability and a signed record of all the specified QC testing.
4
We work with our clients to create Design History Files and Device Master Records. Ensuring they have what they need for successful submissions.
5
ISO 7 (Class 10,000) and ISO 8 (Class 100,000) cleanroom suites and production facilities are fully monitored to ensure environmental compliance.
6
We carry out first article, in-process, and final inspections on every project. In order to deliver market leading quality compliance to all customers.
7
Our team deliver DOE’s, SPC, Capability Studies, Control Plans and Master Plan Validations in order to document and demonstrate compliance at every phase of development.
8
We collate robust corrective & preventative action reports, which help ensure quality is secured at every project stage.
LEARN ABOUT RUA MEDICAL DEVICES
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About Us