Clinical Evaluation Report (CER) makes a strong case for your device and its intended use backed by impactful scientific evidence. The aim of a CER is to reduce the risk that the users and patients are exposed to when using a medical device.
Clinical evaluation is an essential prerequisite for risk management. It justifies the assumptions made in the risk management file, with respect to the benefits and thus the acceptance of a certain risk-benefit ratio.
MEDDEV 2.7/1 Rev 4 of the clinical guidance document was released in June 16 and is aligned more with the European Medical Devices Regulation. The guidelines are more detailed and explicit and help manufacturers to conduct systematic clinical evaluations in a more robust manner so as to demonstrate the efficacy, safety & performance of their device.
The complexity of a Clinical Evaluation Report can vary significantly, but the result should be the same. The performing report should be good enough to read and understood by notified body. It should contain sufficient detail for deciding the data, analysis, and all conclusions to demonstrate device safety for sale in European Markets.
IZiel completes the Clinical Evaluation Report (CER) as per the following changes in revision Med-Dev Rev. 4 with focus on detailing and clarity on every step of the clinical evaluation process that has been conducted by the manufacturers and evaluators.
Biocompatibility testing and evaluations for medical devices is a vital component of patient safety, for it is the only effective means to ensuring that a medical device or any related material, when it happens to come into contact with the patient's body has to not only perform its intended purpose and function; it should also not result in adverse reactions for the patient.
When medical devices and/or materials come into contact with the patient's body, they can cause problems or what may be termed adverse effects that can be either short-term or long-term adverse effects to the body.
These effects, called acute to chronic, can result in mutagenic effects.
It is to prevent the occurrence of such events that biocompatibility testing and evaluations for medical devices has to be carried out.
These evaluations for biocompatibility of medical devices are done to evaluate the interaction between a device and anything it comes into contact with within the patient's body, such as cells, tissue or body fluids.
Essentially, device biocompatibility is assessed to prevent biological risks from happening to the patient.
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