出處:bsi
BSI establishes new regulatory team: Software as a Medical Device (SaMD）
BSI has unveiled a strategic initiative aimed at enhancing its approach to Software as a Medical Device (SaMD) and SaMD with Artificial Intelligence (AI). This move underscores BSI's commitment to fostering innovation while maintaining the highest standards of quality and compliance in the healthcare industry.Effective immediately, BSI has established a dedicated team focused on SaMD and SaMD with AI, led by Thomas Doerge as Global Head.The decision to create a dedicated team for SaMD comes at a time when the healthcare industry is witnessing a surge in software-based medical solutions. By consolidating expertise and resources in this area, BSI aims to streamline its approach, ensuring the delivery of safer, high-quality products to a broader client base in a faster and more efficient manner.The advantages of this strategic move are manifold. SaMD represents the future of healthcare, offering scalable and continuous software development to meet evolving regulatory requirements. By establishing a dedicated team for SaMD applications, BSI aims to stay well ahead in a competitive landscape, marked by the emergence of new regulatory bodies focusing exclusively on software.Moreover, the creation of a focused SaMD entity within BSI reaffirms the organization's commitment to innovation and market leadership. By differentiating itself in the SaMD domain, BSI sets new standards for quality and compliance, positioning itself as a regulatory industry leader in healthcare technology.The new SaMD will be lead by BSI's Thomas Doerge. Resources across BSI will be drawn into the team based on demand for SaMD work, ensuring efficient resource allocation and short lead times in response to growing demand.Global Head SaMD, Thomas Doerge, said: "The creation of this new team shows again that all of us at BSI remain committed to innovation. By creating a dedicated team we are able to set new standards for quality and compliance and position ourselves as a regulatory industry leader in healthcare technology."As BSI positions itself for long-term success, the establishment of a dedicated team for SaMD promotes innovation, whilst maintaining compliance amongst its clients in the healthcare technology sector, ultimately contributing to a healthier and more connected world.
For further details and inquiries, please contact BSI directly.
本網站翻譯：
英國標準協會（BSI）公布了一項戰略計劃，旨在提升其對“軟件作為醫療設備（SaMD）”和帶有“人工智能（AI）”的SaMD的處理方法。此舉強調了BSI在促進創新的同時，在醫療保健行業中保持最高質量標準和合規性的承諾。
BSI立即組建了一個專門致力于SaMD和帶有AI的SaMD的團隊，由托馬斯·多爾格（Thomas Doerge）擔任全球負責人。BSI選擇在此時成立專注于SaMD的團隊，正值醫療保健行業正在見證基于軟件的醫療解決方案的激增。通過整合該領域的專業知識和資源，BSI旨在簡化其處理流程，確保以更快、更高效的方式向更廣泛的客戶群提供更安全、更高質量的產品。
“這一戰略舉措的優勢是多方面的。SaMD（軟件作為醫療器械）代表著醫療衛生的未來，它提供可擴展和持續的軟件開發，以滿足不斷變化的監管要求。通過建立專注于SaMD應用的團隊，BSI旨在競爭激烈的市場中保持領先地位，而競爭激烈的市場正由專注于軟件的全新監管機構的出現所標志。
此外，在BSI內部創建專注于SaMD的實體重申了該組織對創新和市場領導地位的承諾。通過在SaMD領域脫穎而出，BSI為質量和合規性設定了新的標準，將自己定位為醫療技術領域的監管行業領導者。
新的SaMD將由BSI的Thomas Doerge領導。BSI的資源將根據對SaMD工作的需求被抽調到該團隊中，確保資源的有效分配和響應日益增長的需求的短周期時間。”
“全球SaMD主管Thomas Doerge表示：‘新團隊的成立再次表明了我們BSI所有人對創新的堅持。通過成立專門的團隊，我們能夠設定新的質量和合規性標準，并將自己定位為醫療技術領域的監管行業領導者。’
隨著BSI為長期成功定位自己，成立專注于SaMD的團隊促進了創新，同時保持了其在醫療技術領域的客戶之間的合規性，最終為實現更健康、更互聯的世界做出貢獻。如需更多詳情和咨詢，請直接聯系BSI。”
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