醫療器械與健康

泰國，醫療衛生服務部門審核師Ariya Phakagrong

“我審核醫療設備的安全性、性能表現、有效性和監管要求。技術發展如此之快，我有責任保持了解最新進展。例如新冠疫情爆發時，人們推出了多種體外診斷試劑盒來測試COVID-19或其抗體是否存在，這就要求我們在審核前了解相關技術。醫療設備行業的新技術有助于改善生活，但只有在我以最高、最嚴格的標準測試它們時，它們才能做到這一點！”

北美地區，醫療與健康服務總監Adam Menzies

“我的整個職業生涯都是圍繞著醫療產品展開的，但我此前從來沒有感覺到自己正在發揮如此大的作用就我的工作的世界的影響而言，我在TÜV SÜD工作遠超我在其他公司的工作，我每天為醫療行業確認幾十種產品的安全。我睡得很香，因為我知道同事和我已經盡力保護人們免受新醫療技術的潛在有害影響。”

德國，醫療器械和健康測試專家Eke-Henning Hans

“作為測試專家，我監督那些讓生活變得更輕松的醫療產品的開發，比如通過平板電腦控制的智能病床，幫助人們重新行走的外骨骼。熟悉這種高度專業化的技術，并為其開發新的測試程序，這讓我深感激動。我很自豪能夠成為TÜV SÜD這個集團的一員，并為制造更好更安全的產品做出貢獻。我的職業生涯由自己掌握，自己可以設定宏偉目標，努力實現它們。”

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.”