Author Archives: Truesource
氣墊床採購常見5大陷阱｜供應商經驗分享
合規氣墊床供應商怎麼判斷？TFDA、MDR認證採購方必看 對於想採購氣墊床、或尋找氣墊床供應商合作的廠商而言，如何判斷供應商是否合規，是決定合作能否長期穩定的關鍵。以下從認證、產線、售後服務三個面向，說明採購方在評估氣墊床供應商時應該注意的重點。 認證是合規的第一道門檻 醫療器材類產品的採購，認證是不能妥協的基本條件。台灣市場銷售的氣墊床，須取得衛生福利部食品藥物管理署核發的TFDA許可證；若產品要銷往歐盟市場，則必須符合歐盟醫療器材法規MDR（Medical Device Regulation），並於EUDAMED資料庫完成SRN註冊。 檢查認證時的具體做法 要求供應商提供TFDA許可證字號，可至衛福部食藥署官網查詢核實 若涉及外銷歐盟，確認供應商是否已完成MDR認證及EUDAMED註冊 留意認證的有效期限與適用產品範圍，避免認證與實際採購機型不符 詢問供應商是否有EMC驗證、安規測試等相關技術文件 產線與品質管理能力 除了認證文件本身，採購方也應該了解供應商的實際生產與品質控管流程。以淳碩科技為例，我們深耕台灣醫療器材產業超過15年，透過研發團隊與供應商協作的模式，針對每一款氣墊床進行壓力分散效果、氣管條耐用性、電源安規等多項測試，確保產品符合國際標準，才能正式量產上市。 評估產線時可以問的問題 生產流程是否有標準化的品質檢驗機制...
Sep
True Source at Medical Fair Asia 2026, Singapore | Booth #2K16
True Source will be exhibiting at Medical Fair Asia 2026, the region’s premier healthcare exhibition,...
Aug
TRUE SOURCE Anti-Decubitus Air Mattress Since 2009
TRUE SOURCE‘s anti-decubitus air mattress is a self-owned brand carefully managed by TRUE SOURCE Technology...
Apr
TRUE SOURCE at WHX Dubai 2026｜Booth S7.C93
TRUE SOURCE will be exhibiting at WHX Dubai 2026 (formerly Arab Health), part of the...
Dec
TRUE SOURCE at MEDICA 2025｜Düsseldorf Germany Hall
TRUE SOURCE will be exhibiting at MEDICA 2025 in Düsseldorf, Germany, one of the world’s...
Aug
TRUE SOURCE at Medical Taiwan 2025｜Booth P0228
TRUE SOURCE will be exhibiting at Medical Taiwan 2025, taking place from 5–7 June 2025...
May
TRUE SOURCE at Arab Health 2024｜Booth F12
TRUE SOURCE exhibited at Arab Health 2024, one of the world’s largest and most influential...
Dec
TRUE SOURCE at Düsseldorf Germany Hall 6 | Booth # 6L50-3
TRUE SOURCE exhibited at MEDICA 2023 in Düsseldorf, Germany, one of the world’s largest medical...
Sep
TRUE SOURCE Achieves EU MDR 2017/745 Certification
TRUE SOURCE Achieves EU MDR 2017/745 Certification After intensive work by the entire team at...
Aug
TRUE SOURCE at MEDICA 2019｜Booth 6L62b
TRUE SOURCE exhibited at MEDICA 2019, the world’s largest event for the medical sector, from...
Aug