MEDICAL DEVICE STUDIES

CCA specialises in early-stage medical device studies. We can undertake clinical evaluation and regulatory approval for medical devices, active implantables and diagnostic equipment. We have particular expertise in medical devices for therapeutic areas including:

  • Wound Management
  • Peripheral Vascular Disease
  • Cardiovascular Disease
  • Spinal Surgery
  • Orthopaedic Surgery
  • Orthopaedic Trauma and Reconstruction
  • In-vitro diagnostics

We advise on the optimal design of clinical studies based on our deep understanding of regulatory and commercial environments and the operational challenges that this type of study can present.

Medical Device Approval

With new Medical Device Regulations published in 2017, it is more important than ever for companies looking to take medical devices to market to choose a CRO partner to help navigate the approvals process. At CCA, we have proven expertise in helping manufacturers gain timely entry to market.

We have access to a wide range of sites in the UK, US and Europe through our co-ownership of PSN Research.

Our Medical Devices service is led by experienced clinical research professional Shankar Sivshankar.

To discuss your medical device study, contact Shankar Sivshankar, CCA Clinical Research on +44 (0)1392 869933, or connect via LinkedIn.