A single accountable partner for representation, technical documentation and lifecycle compliance across UK, EU, Switzerland, Australia and the United States.
Your regulatory presence in the European Union under MDR 2017/745 and IVDR 2017/746.
MHRA-registered UKRP services for Great Britain market access under UK MDR 2002.
Swissmedic-recognised CH-REP for the Swiss medical device market under MedDO.
TGA Australian Sponsor services for ARTG inclusion and ongoing lifecycle compliance.