出处: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.

本网站翻译：

    英国标准协会（BSI）公布了一项战略计划，旨在提升其对“软件作为医疗设备（SaMD）”和带有“人工智能（AI）”的SaMD的处理方法。此举强调了BSI在促进创新的同时，在医疗保健行业中保持最高质量标准和合规性的承诺。

    BSI立即组建了一个专门致力于SaMD和带有AI的SaMD的团队，由托马斯·多尔格（Thomas Doerge）担任全球负责人。BSI选择在此时成立专注于SaMD的团队，正值医疗保健行业正在见证基于软件的医疗解决方案的激增。通过整合该领域的专业知识和资源，BSI旨在简化其处理流程，确保以更快、更高效的方式向更广泛的客户群提供更安全、更高质量的产品。

    “这一战略举措的优势是多方面的。SaMD（软件作为医疗器械）代表着医疗卫生的未来，它提供可扩展和持续的软件开发，以满足不断变化的监管要求。通过建立专注于SaMD应用的团队，BSI旨在竞争激烈的市场中保持领先地位，而竞争激烈的市场正由专注于软件的全新监管机构的出现所标志。

    此外，在BSI内部创建专注于SaMD的实体重申了该组织对创新和市场领导地位的承诺。通过在SaMD领域脱颖而出，BSI为质量和合规性设定了新的标准，将自己定位为医疗技术领域的监管行业领导者。

    新的SaMD将由BSI的Thomas Doerge领导。BSI的资源将根据对SaMD工作的需求被抽调到该团队中，确保资源的有效分配和响应日益增长的需求的短周期时间。”

    “全球SaMD主管Thomas Doerge表示：‘新团队的成立再次表明了我们BSI所有人对创新的坚持。通过成立专门的团队，我们能够设定新的质量和合规性标准，并将自己定位为医疗技术领域的监管行业领导者。’

    随着BSI为长期成功定位自己，成立专注于SaMD的团队促进了创新，同时保持了其在医疗技术领域的客户之间的合规性，最终为实现更健康、更互联的世界做出贡献。如需更多详情和咨询，请直接联系BSI。”

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