Quality

The Highest Standards of Quality

We have held our ISO 13485 certification since 2006. We are audited annually by the regulatory authorities to ensure we meet the regulations when it comes to compliance.

iso-13485-hold

(Click to download full copy of certificate)

Both of our manufacturing sites are FDA Registered facilities  ( Facility Nos. 3007125292 & 3014255023) and were successfully inspected by the FDA in 2018 and 2014.

RUA Medical has the ethos of building in quality control and statistically valid process methodologies based on written risk assessments early in the design phase of projects

Our operations team work closely with the development team to produce customer specific work instructions.  Our Batch / Lot history records are designed to provide full product traceability and a signed record of all the specified QC testing.  All client specific documents are worked on and agreed with clients.

Our Class 7 (10,000) cleanroom suites and production facilities are fully monitored to ensure environmental compliance.

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