What we do

The full regulatory lifecycle, one senior team

From a foreign manufacturer's first route into the UK and EU, to a deadline transition on an established portfolio. No handoffs to juniors, no learning on your file.

Book a free consultation Start with a Gap Assessment

UK Responsible Person

Your registered UK Responsible Person for the MHRA. We hold your file, handle registration and stand as your point of contact in Great Britain.

MHRA device registration
UK point of contact
Vigilance and incident handling

EU Authorised Representative

Your EU Authorised Representative based in Cork. One partner covers both the UK and the EU after Brexit, on a single contract.

Article 11 EU AR
EUDAMED registration
Import and PRRC support

CE and UKCA Marking

Technical files and design dossiers built to pass. We have constructed more than 500 CE files, every one approved.

Technical documentation
Notified Body strategy
Declaration of Conformity

MDR and IVDR Transition

Move legacy devices onto the new regulations before the deadlines bite. Led the $250M Abbott IVDR programme across nine countries.

Gap analysis to remediation
Clinical and performance evidence
Deadline planning

Software and SaMD

Software as a Medical Device handled end to end, from classification and IEC 62304 to clinical evaluation and post market surveillance.

Classification and risk
IEC 62304 lifecycle
Cybersecurity and PMS

Global Market Access

Beyond the UK and EU. FDA 510(k), Health Canada, MDSAP, and routes into Asia and Australia, coordinated from one team.

FDA 510(k) and QSR
Health Canada and MDSAP
Asia and Australia routes