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
