Medical Device and Diagnostics

Capabilities


  • Medical device consultation
  • Draft, review and finalize clinical strategy/plan
  • Medical writing (Clinical Investigational plan, ICF, IB etc.)
  • ISO14155 and (GCP) Training
  • EC submissions
  • Regulatory opinion
  • Clinical Operations (Start-up, execution and close-out phases)
  • Clinical audit and monitoring
  • Write reports for Clinical Project Management and Site Management (CSR, CER etc.)

Global Partners


CBCC is currently operating with clients based in India, USA, Israel and Europe. Comprehending the regulatory compliance of these countries, we support clients worldwide for CE mark registration, 510(k) registration and device registrations in several other countries.

Clinical and Regulatory Services for Medical Devices


For medical devices, clinical studies form a critical element in the CE marking pathway in the European market. As a regulatory and clinical consultant, our team can ensure that the proposed clinical plan will suffice your requirements. The proposed clinical plan will help you to generate the required evidence to support the clinical performance and safety of the device. We provide clinical strategy/plan for all kinds of devices from class I to class III and all therapeutic categories.

  • Draft, review and finalize clinical strategy/plan
  • Medical writing (Clinical Investigational plan, ICF, IB etc.)
  • Our strength is an in-house team of field experts and a robust network of clinical experts in various therapeutic domains.
  • We provide high quality and regulatory compliant writing services for device clinical studies.
  • ISO14155 & GCP Training
  • EC submissions
  • Regulatory opinion
  • Clinical Operations (Start-up, execution and close-out phases)
  • Clinical auditing and monitoring
  • Clinical Site Management
  • Report writing (CSR, CER etc.)

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