Clinical evidence plan and report for medical devices
The regulatory approval of your device depends on complete clinical evidence!
Get support for structured clinical evaluation, in compliance with FDA guidance and international markets.
Essential for medium and high-risk devices
in FDA submissions!
From the clinical evidence plan to the clinical evaluation report, ready for submission.
To register your medical device with the FDA, it is necessary to demonstrate clinical safety and performance. The CEP (clinical evaluation plan) and the CER (clinical evaluation report) are fundamental documents in this process!
The clinical evidence plan defines the strategy for the clinical evaluation of your medical device, while the clinical evidence report gathers the data and demonstrates that your product is safe for the user.
Who needs a CEP and CER?
High-risk devices:
Products with invasive or critical contact with the human body that require robust clinical evaluation.
Devices in development:
Products that need a clear clinical evidence plan from the early design stages.
Foreign manufacturers:
Companies outside the U.S. that must provide proper clinical data summary and documentation for FDA clearance or approval.
Already cleared devices:
Products previously authorized by the FDA that require updated clinical evidence reports due to changes in design, material, or manufacturing.
Global focus:
Companies seeking alignment with other regulatory markets, such as the European MDR 2017/745.
Your medical device validated with consistent CEP and CER documentation.
Contact Us
We would love to speak with you.
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FAQ
Not all devices require clinical evidence. For many Class I and some Class II devices, non-clinical data may be sufficient. However, medium and high-risk devices—especially Class III PMA submissions—almost always require structured clinical evaluation.
Yes. Scientific literature, real-world evidence, and international studies can be used if they align with FDA requirements. We review your existing data to determine what can be accepted and what needs to be supplemented.
In this case, the FDA may require additional data. Strategies include demonstrating substantial equivalence to a predicate device (for 510(k)), conducting new clinical investigations, or implementing post-market clinical follow-up. A clear clinical evidence plan defines the right pathway.
The timeline depends on the complexity of the device, the submission type (510(k), PMA, De Novo), and the availability of clinical data. We provide a tailored schedule, so that you can track progress and milestones in real time.
If the FDA finds clinical evidence insufficient, they typically issue an Additional Information (AI) Request, which delays the review. If concerns are not resolved, the submission may be rejected. With robust and scientifically grounded documentation, we minimize this risk.
