Samd

Introduction Many recognize the potential of artificial intelligence (AI) in healthcare and life sciences. Some early adopters are starting to reap the benefits already, especially in fields such as radiology and digital pathology, where it is now more common for AI to be used to identify specific markers or patterns in…

軟體預先認證計畫(Pre-cert Program)及AI/ML Framework的核心觀念還是不離醫療器材法規的基本原則，保障安全，確認功效這兩個主軸. 但因應這類產品需要不斷精進的需求，法規上除了要確保以上的主軸，更需要與時俱進符合新世代軟體快速變化的挑戰，所以新式審核機制除了提出建議規範外，也給予製造商彈性的機會。 本文將探討如何在實務面來建 …

AI/ML Framework與Pre-Cert Program可視為下一世代FDA的法規要求，兩種系統在此以全息圖製作以利比較，本文探討兩者異同，以及調和的可能作法。最後則為建立適合下一世代軟體開發組織的建構做前期的鋪陳。 本文的目的在於藉由討論AI/ML Frameworkl與Pre-Cert Program（ 軟體預先認證計畫）差異，提供以下資訊與討論 1.藉由差異的展示，讓讀者對這2個系統有更清楚的認識 2.更清楚了解FDA的思維，如TPLC 3.就個人觀察，未來有很多公司這兩類產品並存的機率很高，故探討如何設計一個設計流程管制機構能同時調和這2類軟體產品的需求 基本核心手法-TPLC 相對於目前的傳統的醫療軟體(SaMD)，FDA對這兩類醫療軟體，採取更有彈性，但要求也更多的作法。 除了醫材管理基本精神-風險為本（Risks based approach)外，導入完整的產品生命週期管理會是進入下個世代管理的里程碑。

In this article, the author summarized the Pre-Cert Program in the form of the requirements in the four components. It can be considered as the specifications of both organization and product level for SaMD company. Introduction The Pre-Cert program is executed in TPLC approach with four components shown as Fig 1…

During the Excellence Appraisal, all organizations would demonstrate the capability to collect and analyze post-launch Real World Performance (RWP) data, whether by instrumenting their SaMD products to generate needed data, or by leveraging alternative data sources. Therefore, FDA expects that these organizations will consistently collect and analyze post-launch data related…

The principal objectives of establishing the streamlined premarket review process component of the Software Pre-Cert Program are to identify the elements necessary for a premarket review and to develop a premarket review process that provides reasonable assurance of safety and effectiveness of a software product from a precertified organization. Elements…

SaMD products included in the Pre-Cert Program will be reviewed via risk-based approach such as IMDRF framework. IMDRF framework is based on the description of intended use of SaMD, which consists of Significance of information provided by SaMD to healthcare decision and State of healthcare situation or condition. …

Organizations that produce safer and more effective device software products not only “do the right things,” but they also “do the things right” based on evidence that informs better decision- making. Excellence Appraisal , the 1st component of Pre-Cert program, is the evaluation upon how the organization “do the things…

Series of studies will be conducted on “The Software Precertification Pilot Program version 1.0 Working Model”, released by FDA, and will be summarized as quick guide reference. This program provides an agile paradigm to accommodate the faster rate of development of SaMD. But quality requirements like CQOE are highly addressed. …