Clearance to Market

Preparing, collating, reviewing, completing, submitting and maintaining Technical Documentation to evidence safety & performance in compliance with national requirements such as EC (MDR, IVDR) CE, Canada (CMDR), MDSAP, US 510k, UK Medical Device Regulations UKCA, UKNI.

Acting as your designated UKRP for UK, completing EUDAMED, MHRA, FDA & other country manufacturer and device registrations

Preparing, compiling relevant safety & clinical performance data for your Design History File(s) (DHF), Risk Management File, Technical Documentation, Design Dossier(s) and Design Master Record(s) (DMR) including: