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