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.

Connect with a Medical Writing Expert Today

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 with a range of Medical Devices Class I, IIa, IIb and III, including coronary stents, sutures, orthopaedic implants, surgical instruments, lenses, EM wave therapies, dermatology devices

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.

CLINEXEL is a professionally managed Company, a CRO is led by experts with experience in leadership positions in pharma and biotech companies.

QUICK LINKS

LET's CONNECT

Our experts will be happy to speak with you to understand your challenges and propose optimum cost-efficient solution.
Write to us at : info@clinexel.com

Contact us

Social Links

Linkedin

Clinexel©2023. All Right Reserved.

Develop by Softtonia