Clinical Evidence

Depending on the risk classification of your Medical Device, you may or may not be required to provide Health Authorities with clinical evidence to be able to commercialize your product.

As a CRO with a focus on quality and cost-effectiveness, we stand out by offering tailored solutions for the generation of clinical evidence for your without depleting your complete budget, Opera is optimally suited to assist you with clinical trial management.

Key activities:

  • Medical Writing

  • Clinical Monitoring

  • Quality Control

  • Clinical Operations

  • Safety Vigilance

  • Medical Monitoring

  • Medical Device Biometrics