Our Services

Regulatory Consulting

Regulatory Consulting

Technical Documentation

MDR Technical Documentation

SaMD & Software Compliance

SaMD & Software Compliance

External PRRC & QMR

External PRRC & QMR

In-Country Representation

In-Country Representation

Micro Consulting

Micro Consulting

Request Support for Your Medical Device Regulatory or SaMD Compliance

Get expert help with MDR, UKCA, TGA, or Medsafe – from classification to approval and ongoing compliance.