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。
Indication on if the technological know-how is new, new software of existing technological innovation or whether it is an innovation
Stage three - Investigation with the clinical facts: This phase handles the analysis of the collected knowledge. Evaluators will attract conclusions concerning the system’s compliance with protection and effectiveness necessities together with establish any residual risks, uncertainties, or unanswered inquiries.
In case you are a user of Formwork, our eQMS computer software, It can save you lots of time by deciding on “QMS” on the best menu and “OpenRegulatory Templates” on the still left menu, after which you can opening the relevant folder to discover this template ready to load into Formwork.
針對某些已有標準療法的疾病，醫師可直接參考此電腦自動化的決策系統提供的治療方案。
對整體證據的評論與總結不足 (Inadequate critique and summary in the totality of proof delivered for the device)
「Clinical evaluation of medical devices that are determined by existing, proven systems and meant for a longtime use from the know-how is most likely to count on compliance with recognised benchmarks and/or literature evaluation and/or clinical knowledge clinical evaluation report of equivalent devices.
A important goal in the clinical evaluation is to establish that any risks connected to the usage of the medical device are appropriate when weighed against the advantages to your individual and are appropriate by using a substantial level of defense of well being and protection.
These are just some of the a lot of capabilities of the one objective-developed solution for medical devices.
A scientific validity report is used To guage the overall performance of an IVD device, Based on IVDR Regulation 2017/746. You need to do that early while in the lifetime of one's IVD In case you are introducing a whole new solution to the market.
Enhancement and approval of medical devices, write-up-marketing and advertising surveillance
If the info are appropriate to certain elements of the intended purpose or promises, are they suitable to a certain design, dimension, or setting of your product?
1. an identification of the final basic safety and functionality needs that need assistance from appropriate clinical facts; (識別需透過 Clinical info 支持的 GSPRs)
How usually will be the CER up to date, and what triggers an update? What procedures are in spot for making sure the CER remains present?