Performance Evaluation Studies

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Does your IVD device require appropriate clinical evidence? With regard to your IVD Performance Evaluation Studies, we are glad to assist you.

Are you looking for a qualified partner to produce accurate and reliable clinical proof for your IVD device that complies with all relevant rules and guidelines?

We are delighted to assist you with your IVD Performance Evaluation Studies, thanks to our IVD experts. Please get in touch with us if you want more details. The IVD regulation DRAP and the WHO have outlined criteria that manufacturers of IVD devices must adhere to in order to protect the safety and functionality of IVD devices. An IVD Performance Evaluation Study should include the following three components, per the regulatory requirements on In Vitro Diagnostic Products:

  • Report on scientific truth
  • research on clinical performance
  • studies of the effectiveness of analysis

In order to help our clients and partners to produce high-quality clinical evidence that complies with the relevant guidance and demonstrates the effectiveness of their IVD devices, MedWatch Global draws on its extensive understanding of IVD regulations and guidelines, so we provide analytical and clinical performance studies in association with esteemed clinical laboratories as blood banks and state-of-the-art private laboratories in Europe.

Our Performance Evaluation Study service includes:

  • Qualification of and communication with the evaluation center
  • Training and monitoring of the study site
  • Drafting evaluation protocols
  • Data source verification and data analysis
  • Compiling performance study reports for the technical documentation of your IVD device Our studies will be conducted in line with the standard ISO 20916:2019 in vitro diagnostic medical devices (clinical performance studies using specimens from human subjects) good study practice, and will comply with the national or regional requirements for ethics committee approval.

The design of the protocols and reports will be in line with the IVD Regulation, hence will meet the notified body’s expectations.