医疗器械与健康

泰国，医疗卫生服务部门审核师Ariya Phakagrong

“我审核医疗设备的安全性、性能表现、有效性和监管要求。技术发展如此之快，我有责任保持了解最新进展。例如新冠疫情爆发时，人们推出了多种体外诊断试剂盒来测试COVID-19或其抗体是否存在，这就要求我们在审核前了解相关技术。医疗设备行业的新技术有助于改善生活，但只有在我以最高、最严格的标准测试它们时，它们才能做到这一点！”

北美地区，医疗与健康服务总监Adam Menzies

“我的整个职业生涯都是围绕着医疗产品展开的，但我此前从来没有感觉到自己正在发挥如此大的作用就我的工作的世界的影响而言，我在TÜV SÜD工作远超我在其他公司的工作，我每天为医疗行业确认几十种产品的安全。我睡得很香，因为我知道同事和我已经尽力保护人们免受新医疗技术的潜在有害影响。”

德国，医疗器械和健康测试专家Eke-Henning Hans

“作为测试专家，我监督那些让生活变得更轻松的医疗产品的开发，比如通过平板电脑控制的智能病床，帮助人们重新行走的外骨骼。熟悉这种高度专业化的技术，并为其开发新的测试程序，这让我深感激动。我很自豪能够成为TÜV SÜD这个集团的一员，并为制造更好更安全的产品做出贡献。我的职业生涯由自己掌握，自己可以设定宏伟目标，努力实现它们。”

Dr. Andreas Stange, Vice President for Medical Health Services In-Vitro Diagnostics, Japan

“Covid-19 and blood group tests have one thing in common: they must be safe and deliver valid results. At TÜV SÜD Medical Health Services we certify medical devices and management systems, with a special focus on in-vitro diagnostics. I help clients all over the world certify that they fulfill legislative requirements in a highly regulated industry. That means I have to keep up to date with both regulatory changes and wrap my head around breakthrough innovations first-hand. I love working for an employer that opens so many opportunities and career paths for professionals with a technical expertise.”

Dr. Sabina L. Hoekstra-van den Bosch, Regulatory Strategy Principal Medical and Health Services, Netherlands

“I look back on more than 20 years of experience in regulatory affairs within the pharmaceutical and medical device sector. I am seeking to improve the exchange among Notified Bodies and strengthen our position in the conversation with regulatory authorities at a European level. One example: At the moment new European legal frameworks are challenging our processes at TÜV SÜD. Here it is especially important for us to remain in constant connection with industry and regulatory authorities to overcome initial difficulties and uncertainties, that new regulations almost inevitably entail.”