Details, Fiction and Clinical evaluation report for medical devices
Details, Fiction and Clinical evaluation report for medical devices
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由各領域的專家學者整理單一主題的多篇研究或系統回顧而成,有很具體的研究成果與臨床建議,同時也有同儕審查機制,因此正確性高,且具權威性。
As a solution supplier, MakroCare features right approach beginning with Hole Investigation within your existing CER (if an Update is needed), all accessible information from clinical to security to threat administration to literature ahead of arriving on appropriate CEP.
Phase three - Assessment of your clinical details: This stage covers the Investigation of your gathered details. Evaluators will attract conclusions concerning the device’s compliance with safety and overall performance necessities together with establish any residual challenges, uncertainties, or unanswered questions.
Distinct statement regarding compliance to prerequisites. Acceptability of the danger-reward profile In line with latest awareness/state from the art while in the medical fields and As outlined by out there medical options.
Robust expertise in all suitable sections of your applicable rules together with IVDR, IMDRF rules and Many others
Technical efficiency is verified by the examination and provision of goal evidence that the MDSW specs conform to consumer requires and intended uses, and that the necessities carried out may be continually fulfilled.
沒有臨床專家認可差異不會對安全與功效產生不良影響 (No endorsement by the clinical qualified which the variances won't adversely affect the security or functionality in the gadget)
Remember to give a summary of the usability engineering both deriving from different documents or the risk administration.
The clinical evaluation report as well as applicable clinical details constitute the clinical proof for conformity assessment.
You remain permitted to use literature info, it will eventually must be up to date as section of your respective submit-promoting clinical stick to-up activities in any case.
You might want to consolidate the responses to the final requirements of the regulation already addressed in your technical documentation:
若使用類似品,則評估是否有足夠的臨床資料證明與目標醫材的等同性 (In case of feasible clinical evaluation report equivalence to an existing device, Assess if you'll find clinical facts readily available and ascertain equivalence);
Describe listed here the seek out challenges and usefulness similar risks with the use of the gadget. State the filters used in your search.
Correct description in the supposed purpose as described while in the machine's IFU with specific medical indications (if applicable); statements manufactured in out there promotional resources. This portion summarizes: