Medical Devices

Medical Devices

MEDICAL DEVICES

We offer customised solutions for regulatory process related to all categories and classes of medical devices across markets,
including EU (MDR and related), USFDA (510k and related), UK (UKCA and related). We are well-versed with MDR, IVDR, and SaMD requirements.

Medical Device/Drug-Device Combination

  • EU MDR 2017/745 for CE marking
  • MEDDEV 2.7.1 Rev 4
  • UK MDR 2002 for UKCA marking
  • USFDA 510k
  • USFDA Premarket Approval

In-Vitro Diagnostics (IVD)

  • EU IVDR 2017/746
  • USFDA 510k
  • USFDA Premarket Approval

Software as a Medical Device (SaMD)

  • Medical device data systems
  • Clinical decision support
  • Mobile medical apps
  • Software pre-certification
  • Real-world performance
  • Artificial intelligence (AI) and Machine Learning (ML)
  • Digital therapeutics (DTx)