ClinServ is now the First international CRO conducting Medical devices clinical trials in the Middle East and Africa in addition to providing Regulatory, Clinical Investigations, and Post Marketing Surveillance Registries’ services for Medical Devices. Our Services include but not limited to:

   Regulatory Services
  • Preparation and Documentation of the following:
    • Premarket Notification 510 (k) -21 CFR Part 807 Subpart E
    • Premarket Approval (PMA) -21 CFR Part 814
    • Investigational Device Exemption (IDE) - 21CFR Part 812
    • Product Development Protocol
    • Medical Device Reporting - 21 CFR Part 803

   Project Management and Study Monitoring of Medical Devices Clinical Trials.
   Investigational Medical devices logistics Management
   Quality Assurance
   Medical Writing

The applicable GCP standards for medical device investigation which is laid down in EN ISO 14155-1/2 & US legalization (21 CFR 812) is extensively adopted by ClinServ.
  Project Management

  Study Monitoring

  Medical Writing

  Medical Devices

  Regulatory Affairs

  Site Management

  Training and Development

  Data Management & Statistics

  Biological and IMP Logistics

  Quality Assurance