Clinical data

We provide comprehensive support for medical device clinical data requirements in compliance with EU MDR and applicable guidelines.

Clinical Evaluation Documentation

We develop the essential documentation for regulatory compliance:

• Clinical Evaluation Plans (CEP)

• Systematic literature reviews

• Clinical Evaluation Reports (CER)

• Analysis of existing clinical data

• Evidence of device safety and performance

  
  

Clinical Studies Support

For devices requiring clinical investigations:

• Study design aligned with ISO 14155 (GCP)

• Regulatory submissions for clinical studies

• Support for FDA, EU, and local regulations compliance

• Assistance with ethics committee submissions