IVDR compliance
The performance evaluation of an In vitro Diagnostic (IVD) aims to ensure that the IVD delivers consistent and clinically meaningful results, enabling users to make accurate diagnoses and treatment decisions. This process is crucial for regulatory approval, quality assurance, and the overall reliability of diagnostic tools in healthcare settings.
Your IVD market authorization partner
Who must prepare PEP/PERs?
Under the IVDR 2017/746 in Europe, the responsibility for performing performance evaluations for IVDs primarily lies with the manufacturers of the IVDs.
Manufacturers are obligated to establish performance evaluations to demonstrate that their devices meet the intended performance characteristics and claims.
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IASON consulting can assist you in preparing Performance Evaluation Plans (PEPs) and Reports (PERs).
Always compliant
Performance evaluations necessitate the demonstration of scientific validity, analytical performance and clinical performance to ensure safety, performance, and benefit-risk assessment. We consistently support you in meeting these regulatory demands.
Injecting experience
Injecting experience is vital for your company as our extensive knowledge can be leveraged by manufacturers to enhance product development, compliance, and overall success in the market.
Reducing workload
Creating a thorough performance evaluation demands extensive research, data analysis, and documentation, which can strain internal resources in terms of time and effort. We can assist you in alleviating this resource burden.
The process
At IASON, we believe that efficient communication and robust client interfacing are the cornerstones of successful project execution. In the complex and highly regulated landscape of medical device development, clear, timely, and transparent communication is not just an added advantage—it's a necessity.
Request the preparation of PEP and PER.
Meet your consultant and lead writer in an online or on-site kick-off meeting to discuss your IVD, project timelines, review times and the data necessary to complete it.
You will receive a list of critical and non-critical documentation that we require to begin the project.
We carefully prepare the performance evaluation documents for you. If you have any questions or comments during this project, we will be available for you.
Within the designated timeline, you will receive the draft PEP and PER for you review. We will incorporate your feedback from review cycles and finalize the documents.
It is done! We will send you the finalized, signed reports. If desired, we debrief the project in a closure meeting.
It was a pleasure to work with you!