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.

IVD EVALUATION STUDIES

Protecting the safety and efficacy of IVDs and their performance

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, as per the EU Regulation 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 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 knowledge of IVD laws and guidelines.

Due to this, we work with renowned clinical labs, blood banks, and cutting-edge private laboratories in Europe to provide analytical and scientific services.

Our performance evaluation studies includes:

  • Communication with the assessment center and eligibility
  • Training and observation of the research location
  • Developing evaluation procedure draughts
  • Data research and confirming data sources
  • Assembling performance study results for your IVD device’s technical documentation

Our research will be done in accordance with the good study practices outlined in the ISO 20916:2019 standard for in vitro diagnostic medical devices (clinical performance studies using specimens from human subjects) and will meet any local, state, or federal standards for ethics committee approval.

The protocols and reports will be created in accordance with the IVD Regulation, which will satisfy the requirements of the notified authority.