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(wǎng)站翻譯：
英國(guó)標(biāo)準(zhǔn)協(xié)會(huì)（BSI）公布了一項(xiàng)戰(zhàn)略計(jì)劃，旨在提升其對(duì)“軟件作為醫(yī)療設(shè)備（SaMD）”和帶有“人工智能（AI）”的SaMD的處理方法。此舉強(qiáng)調(diào)了BSI在促進(jìn)創(chuàng)新的同時(shí)，在醫(yī)療保健行業(yè)中保持最高質(zhì)量標(biāo)準(zhǔn)和合規(guī)性的承諾。
BSI立即組建了一個(gè)專門致力于SaMD和帶有AI的SaMD的團(tuán)隊(duì)，由托馬斯·多爾格（Thomas Doerge）擔(dān)任全球負(fù)責(zé)人。BSI選擇在此時(shí)成立專注于SaMD的團(tuán)隊(duì)，正值醫(yī)療保健行業(yè)正在見(jiàn)證基于軟件的醫(yī)療解決方案的激增。通過(guò)整合該領(lǐng)域的專業(yè)知識(shí)和資源，BSI旨在簡(jiǎn)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(zhì)量的產(chǎn)品。
“這一戰(zhàn)略舉措的優(yōu)勢(shì)是多方面的。SaMD（軟件作為醫(yī)療器械）代表著醫(yī)療衛(wèi)生的未來(lái)，它提供可擴(kuò)展和持續(xù)的軟件開(kāi)發(fā)，以滿足不斷變化的監(jiān)管要求。通過(guò)建立專注于SaMD應(yīng)用的團(tuán)隊(duì)，BSI旨在競(jìng)爭(zhēng)激烈的市場(chǎng)中保持領(lǐng)先地位，而競(jìng)爭(zhēng)激烈的市場(chǎng)正由專注于軟件的全新監(jiān)管機(jī)構(gòu)的出現(xiàn)所標(biāo)志。
此外，在BSI內(nèi)部創(chuàng)建專注于SaMD的實(shí)體重申了該組織對(duì)創(chuàng)新和市場(chǎng)領(lǐng)導(dǎo)地位的承諾。通過(guò)在SaMD領(lǐng)域脫穎而出，BSI為質(zhì)量和合規(guī)性設(shè)定了新的標(biāo)準(zhǔn)，將自己定位為醫(yī)療技術(shù)領(lǐng)域的監(jiān)管行業(yè)領(lǐng)導(dǎo)者。
新的SaMD將由BSI的Thomas Doerge領(lǐng)導(dǎo)。BSI的資源將根據(jù)對(duì)SaMD工作的需求被抽調(diào)到該團(tuán)隊(duì)中，確保資源的有效分配和響應(yīng)日益增長(zhǎng)的需求的短周期時(shí)間。”
“全球SaMD主管Thomas Doerge表示：‘新團(tuán)隊(duì)的成立再次表明了我們BSI所有人對(duì)創(chuàng)新的堅(jiān)持。通過(guò)成立專門的團(tuán)隊(duì)，我們能夠設(shè)定新的質(zhì)量和合規(guī)性標(biāo)準(zhǔn)，并將自己定位為醫(yī)療技術(shù)領(lǐng)域的監(jiān)管行業(yè)領(lǐng)導(dǎo)者。’
隨著BSI為長(zhǎng)期成功定位自己，成立專注于SaMD的團(tuán)隊(duì)促進(jìn)了創(chuàng)新，同時(shí)保持了其在醫(yī)療技術(shù)領(lǐng)域的客戶之間的合規(guī)性，最終為實(shí)現(xiàn)更健康、更互聯(lián)的世界做出貢獻(xiàn)。如需更多詳情和咨詢，請(qǐng)直接聯(lián)系BSI。”
翼弘您提供專業(yè)的體系認(rèn)證咨詢指導(dǎo)：ISO9001、IATF16949、ISO22000、ISO14001、ISO27001、HACCP、GB/T27922 、GB/T50430、GB/T31950、GB/T29490、AAA信用認(rèn)證、CMMI、QGO8000、SA8000等
聯(lián)系人：張老師
電話/微信：13681722151
