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Acceptance criteria

What are acceptance criteria?
The clinical evaluation of your medical device (or performance evaluation of your in-vitro diagnostic medical device) must include a description of potential acceptance criteria including performance criteria and safety criteria. The performance criteria will be used to demonstrate that your device performs at a similar level to other benchmark devices / the standard of care. The safety criteria will be used to demonstrate that your device is as safe as other benchmark devices / the standard of care.
AML Christensen’s service

At AML Christensen we know how to establish potential acceptance criteria. These will typically be established based on a review of the literature for other similar benchmark devices or on the generally acknowledged state of the art. As such, it is important to include relevant search terms when developing the literature search strategy as part of the Clinical Evaluation Plan (CEP) for your device.

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Address:


AML Christensen ApS

Agern Allé 5A
2970 Hoersholm, Denmark

CVR. 41553006

Contact:


E-mail: anna@amlchristensen.com
Phone: +45 23 67 16 00

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