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  1. 1. ²Ó­MªvÀø²£«~Á{§É¸ÕÅç³]­p»P¼Æ¾Ú¤ÀªR (²V¦¨0714-0813(¤u¬ã°|¥x¥_¾Ç²ß¤¤¤ß))
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  2. 2. ¾÷±ñ²£·~µ²¦X¼Æ¦ì²£«~Å@·Ó(DPP)¤§À³¥Î (²V¦¨0714(¤u¬ã°|¥x¥_¾Ç²ß¤¤¤ß))
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  3. 3. ·sª©¼Ú·ùMDR»P­^°êUKCAÂåÀø¾¹§÷ªk³W¹ê°È (½u¤W0716-0717(¤u¬ã°|¥x¥_¾Ç²ß¤¤¤ß))
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    ¡@½Ã¥ÍºÖ§Q³¡©ó 2021 ¦~ 5 ¤ë 1 ¤é¬I¦æ¡uÂåÀø¾¹§÷§Þ³N¤H­ûºÞ²z¿ìªk¡v¡A³W©w¿é¤JÂåÀø¾¹§÷§Þ³N¤H­ûÀ³¦³ªñ 5 ¦~¤º±µ¨ü¦Ü¤Ö 20 ¤p®É¥H¤W¤§±Ð¨|°V½m¡FµL½×¬OÂåÀø¾¹§÷»s³y·~©Î³c½æ·~ªº§Þ³N¤H­û¡A©ó·~ªÌ¨Ìªk¿ì²zµn°O¤§¤é°_¡A¨C¦~À³±µ¨ü 8 ¤p®É ...
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  4. 4. ÃÄ«~¿é¤J·~ªÌªì¶¥°ö°V¨t¦C-ÃÄ«~¬dµnCTD¸ê®Æ·Ç³Æ»P (0718(¤u¬ã°|¥x¥_¾Ç²ß¤¤¤ß))
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  5. 5. ISO 14971¡G2019 ÂåÀø¾¹§÷­·ÀIºÞ²z½Òµ{ (¥x¥_³õ¡A07/21)
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    ISO 14971§ïª©ªº¥D­n¥Øªº¡A¬OÀ°§UÂåÀø¾¹§÷»s³y°ÓÃѧO¦M®`¨Ã¦ô­p»PÂåÀø¾¹§÷¬ÛÃöªº­·ÀI¡A¥H½T«O­·ÀI¯à¦³®ÄºÊ±±»P¹ê¬I¡A°ò©ó³o­Ó­ì«h¡AISO°ê»Ú¼Ð·Ç²Õ´¶¶À³¤F·í«eªº¥«³õ»Ý¨D¡A·s¼W©Î­×§ï±M¦³¦Wµüªº¸ÑÄÀ¡A¨Ã½Õ¾ã¤F­·ÀIºÞ²z¤¤ªº¨BÆJ©Î¬yµ{»¡©ú¡A¥H½T«O ...
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  6. 6. ISO 11737¼Ð·Ç»P¹ê°È (¹êÅé0723(¤u¬ã°|¥x¥_¾Ç²ß¤¤¤ß))
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    • [2025/07/23]
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    ÂåÀø¾¹§÷·L¥Íª«ÀËÅç»P¹êÅç«ÇºÞ²z°ö°V¯Z-ISO 11737¼Ð·Ç»P¹ê°È(«Øºc¾Ç­û¹ï·L¥Íª«ÀËÅç¡B ISO11737¼Ð·Ç¡BÀËÅç¤èªk»P¹êÅç¾Þ§@¡B¹êÅç«Ç³W¹º»PºÞ²zµ¥¦³°ò¥»·§©À¤Î¹ê°ÈÀ³¥Î¯à¤O¡A¥H´Á¨ó§U¥ÍÂå²£·~»s³y·~ªÌ§Ö³t´xÂåÀø¾¹§÷·L¥Íª«ÀËÅç©MISO 11 ...
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  7. 7. ÂåÀø¾¹§÷«~½èºÞ²z¨t²Î¤§¹q¸£³nÅé»P¥Í²£»sµ{½T®Ä°V½m (0724(¤u¬ã°|¥x¥_¾Ç²ß¤¤¤ß))
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    ÂåÀø¾¹§÷«~½èºÞ²z¨t²Î©Îªk³W¤¤¡A¦pISO 13485¡BTFDAÂåÀø¾¹§÷«~½èºÞ²z¨t²Î·Ç«h(QMS)¡BFDA QMSR¡B¼Ú·ùEN ISO 13485§¡¹ï«~½èºÞ²z¨t²Î¤¤©Ò¨Ï¥Î¤§¹q¸£³nÅé»P¯A¤Î»Ý½T®Äªº¥Í²£»sµ{¡A©ó¸Ó¹q¸£³nÅé¨Ï¥Î«e¤Î²£«~¶q²£«e­n¨D¶i¦æ½T ...
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  8. 8. MDR§Þ³N¤åÀÉ»P«~½èºÞ²z¨t²Î (DNV°ö°V¾Ç°| 2025/07/31-08/01)
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    • [2025/07/31]
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    MDR General Safety and Performance Requirements & Technical Documentation Introduction and Requirements ¼Ú·ùÂåÀø¾¹§÷ªk³W-¤@¯ë¦w¥þ¦³®Ä ...
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  9. 9. MDR¼Ú·ùÂåÀø¾¹§÷ªk³W-¤@¯ë¦w¥þ¦³®Ä­n¨D»P§Þ³N¤åÀÉ (DNV°ö°V¾Ç°| 2025/07/31)
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    MDR General Safety and Performance Requirements & Technical Documentation Introduction and Requirements / ¼Ú·ùÂåÀø¾¹§÷ªk³W-¤@¯ë¦w¥þ¦³ ...
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  10. 10. MDR¼Ú·ùÂåÀø¾¹§÷ªk³W-«~½èºÞ²z¨t²Î¬ã²ß½Òµ{ (DNV°ö°V¾Ç°| 2025/08/01)
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    MDR QMS System Advanced course ¼Ú·ùÂåÀø¾¹§÷ªk³W-«~½èºÞ²z¨t²Î¬ã²ß½Òµ{
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