Your Trusted Partner For Clinical Research and Pharmacovigilance

Medical Devices

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.

CLINEXEL SERVICES

Post Marketing Clinical Follow-up (PMCF) studies for marketed devices

    • Pilot clinical trials -investigational devices
    • Pivotal clinical trials for investigational devices
    • Clinical Evaluation Plans and Clinical Evaluation Reports
    • Performance Evaluation Plans and Performance Evaluation Reports
    • Materiovigilance

CLINEXEL EXPERTISE

  • Strong knowledge of EU MDR and IVDR
  • Well versed with India Medical Device Rules
  • Good understanding of ICH E6 and ISO:14155
  • ISO certified for QMS & ISMS
  • Experience on a range of Medical Devices Class I, IIa, IIb and III, including coronary stents, sutures, orthopaedic implants, surgical instruments, lenses, EM wave therapies

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.