Your Trusted Partner For Clinical Research and Pharmacovigilance


CLINEXEL experts have rich experience in medical device and pharma industry. CLINEXEL team has experience with following devices- stents, ventilators, intraocular lens, respiratory devices, orthopaedic devices, electromagnetic radiation emitting devices, sutures and gloves.

We provide following services for Medical Device Industry:

  • Pilot clinical trials for investigational devices
  • Pivotal clinical trials for investigational devices
  • Post Marketing Clinical Follow-up (PMCF) studies for marketed devices
  • Preparation of Clinical Evaluation Plans and Clinical Evaluation Reports
  • Pharmacovigilance activities for Medical Devices including preparation of PSURs

CLINEXEL team is well versed with

  • ISO 14155:2020
  • EU-Medical Device Regulation
  • Medical Device Rules, India

Based on our experience, WE provide strategic regulatory and clinical support for the regulatory approval and CE marking of medical devices.