Compliance

Regulatory compliance

Market-specific compliance guides for EU, FDA, UK, and GCC.

EU MDR 2017/745

Our ISO 13485-aligned manufacturing supports CE marking. We provide technical file documentation for your Notified Body submission.

FDA 510(k)

We provide device description, material specifications, and QC records to support your 510(k) submission for surgical instruments.

UK MHRA

UKCA pathway supported with appropriate documentation and PRRC support.

SFDA / MOHAP (GCC)

Active exports to Gulf markets with Certificates of Conformance and ISO certification.