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Concise physical and technological product description and supposed software. Outline of intended therapeutic or diagnostic claims. Clinical evaluation and information kinds. Summary of clinical info and evaluation.
That’s why we really know what brokers are expecting, we will prepare your workforce and documentation accordingly for their technical specs.
The CER is distinct to 1 gadget and must be continually current all through the lifestyle-cycle of the document, and so desires continual upkeep.
⇒ Reports performed to assess the security and general performance with the product called clinical investigation
如何知道是否有「足夠」的資料量和品質呢？這應該看似又是主觀判斷，但可參考下面解釋：
缺少關於「效度」的討論 (Deficiency of discussion of the validity or usually of end result steps utilized)
The report for set up devices can rely upon existing current market information, Whilst novel devices need knowledge from equivalent and equal devices.
We have an understanding of the importance of CERs in demonstrating the safety and efficiency of the medical system. That’s why we have a meticulous method of every step from the documentation, from facts selection and Assessment to report writing and NB submission.
Current report to be submitted to Notified Physique or knowledgeable authorities when requested or all through an yearly surveillance audit
MDR necessitates medical device companies to post a Clinical Evaluation Report (CER) to offer proof that they have performed a clinical evaluation and that it's established the protection and efficacy from the system.
Precision In this particular Evaluation and the selection of chosen medical indications and target populations may well minimize the amount of clinical information desired from added clinical investigations.」
Provide an summary on Clinical evaluation report for medical devices the unit’s developmental context, including its present-day current market presence in Europe or other countries, the period of its presence, and the quantity of devices positioned that you can buy. Consider incorporating details from suitable publications to counterpoint this chapter.