Establishing your device’s safety and performance is a critical component of the clinical evaluation process. However, how to use the state of the art section within the Clinical Evaluation Report (CER) and Performance Evaluation Report (PER) to establish the device's safety and performance objectives and acceptance criteria can seem ambiguous.
Download our white paper to learn...
- the difference between safety and performance objectives and acceptance criteria
- how to use the state of the art to identify meaningful safety and performance objectives
- how to establish the device's acceptance criteria and justify these criteria for the benefit-risks profiles used to generate MDR and IVDR compliant CERs and PERs
The Criterion Edge Team
There’s no substitute for experience. Not just writing experience, but industry experience – collectively, the CE team represents over 4 decades of direct industry experience. The team is among the best in the business. Top-flight, advanced-degree clinical professionals with years of experience writing an array of regulatory reports for medical device manufacturers and pharmaceutical and biologics companies.
To learn more about how Criterion Edge can help you achieve your regulatory goals, see criterionedge.com, or contact the company at info@criterionedge.com or, by phone, at +1-805-202-5520
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