ÅëÇÕ°Ë»ö
ä¿ëÁ¤º¸
ÇìµåÇåÆÃ
ÀÎÀçÁ¤º¸
Ä¿¹Â´ÏƼ
Àαâ°Ë»ö¾î
:
¿µ¾÷
¸¶ÄÉÆÃ
ÀÓ»ó
¿¬±¸
Ç°Áú°ü¸®
ÀλçÃѹ«
»ý»êÁ÷
¾à»ç
ÀÎÇã°¡
°£È£»ç
- À̹ÌÁöºä -
(400x300)
¹ÙÀÌ¿À°øÁ¤(Device, Á¦Çü¿¬±¸) - ¹ÙÀÌ¿ÀÀǾàÇ°ÀÇ Drug-device combination °³¹ß µî
http://www.hrkorea.co.kr
ȸ»ç¸í
HRKorea
´ëÇ¥ÀÚ
¼Á¾¿ø
»ç¿ø¼ö
35¸í
ÀÚº»±Ý
25¾ï¿ø
»ç¾÷³»¿ë
Á÷¾÷Á¤º¸Á¦°ø
¸ðÁýÁ÷Á¾
¿¬±¸/ÀÓ»ó/°³¹ß/Åë°è
£¾
°³¹ß/RA/´ë°ü
±Ù¹«Áö¿ª
¼¿ï
ÀüÁö¿ª
´ã´ç¾÷¹«
¹ÙÀÌ¿À°øÁ¤(Device, Á¦Çü¿¬±¸) - ¹ÙÀÌ¿ÀÀǾàÇ°ÀÇ Drug-device combinat
¸ðÁýÀοø
1
¸í
±Ù¹«ÇüÅÂ
Á¤±ÔÁ÷
±Þ¿©»çÇ×
ÃßÈÄÇùÀÇ
ÀÚ°Ý¿ä°Ç
¼ºº°
¹«°ü
³ªÀÌ
¹«°ü
ÇзÂ
´ëÇпø(¼®»ç) Á¹¾÷
¡è
°æ·Â
3³â
¡è
»ó¼¼¸ðÁý³»¿ë
¹ÙÀÌ¿À°øÁ¤(Device, Á¦Çü¿¬±¸) - ¹ÙÀÌ¿ÀÀǾàÇ°ÀÇ Drug-device combination °³¹ß µî
[Á÷À§]
ÁÖÀÓÀÌ»ó (°æ·Â 3³âÀÌ»ó)
[ÇзÂ/Àü°ø]
¼®»çÀÌ»ó, ºÐÀÚ»ý¹°ÇÐ, »ý¸í°úÇÐ, »ýÈÇÐ µî °ü·ÃÇаú
[´ã´ç¾÷¹«]
* ¹ÙÀÌ¿ÀÀǾàÇ°ÀÇ Drug-device combination °³¹ß
(pre-filled syringe, autoinjector, on-body injector µî)"
- °³¹ß Àü·« ¼ö¸³ ¹× timeline °ü¸®
- ÇØ¿Ü À§Å¹¿¬±¸¾÷ü / À§Å¹Á¦Á¶¾÷ü °ü¸®
" - Medical device ±¹Á¦ ±ÔÁ¦»çÇ× ±â¹Ý ¾÷¹« ¼öÇà
(device design controls process ¼ö¸³, device design history file (DHF) °ü¸®, device risk management process ¹®¼ ÀÛ¼º ¹× °ü¸® µî)"
" - ¹ÙÀÌ¿ÀÀǾàÇ° Çã°¡ ½Ã device °ü·Ã ´ëÀÀ
(Çã°¡ ¹®¼ ÀÛ¼º ¹× º¸¿Ï ´ëÀÀ, MDR¿¡ µû¸¥ NB opinion ȹµæ)"
[Çʼö»çÇ×]
À¯°ü°æ·Â 3³â ÀÌ»ó
[¿ì´ë»çÇ×]
DP device °³¹ß °æÇèÀÚ
¹Ì±¹ ¹× À¯·´ À¶º¹ÇÕÀÇ·áÁ¦Ç° Çã°¡ °æÇèÀÚ
¿µ¾î È¸È / OA ´ÉÅëÀÚ
¹Ú»çÇÐÀ§ º¸À¯ÀÚ
[¼·ùÁ¢¼ö]
ÀÌ ¸á : kschoi@hrkorea.co.kr
´ã´ç : HRKoreaÃÖ°æ¼÷ºÎ»çÀå
Tel : 02-3450-1263
Á¢¼ö±â°£
2024³â 12¿ù 31ÀÏ ±îÁö
Á¢¼ö¹æ¹ý
À̸ÞÀÏ, ¿Â¶óÀÎÁ¢¼ö
À̷¼¾ç½Ä
¿Â¶óÀÎ À̷¼
´ã´çÀÚ
ÃÖ°æ¼÷
¿¬¶ôó
02-3450-1263
À̸ÞÀÏ
kschoi@hrkorea.co.kr
ȨÆäÀÌÁö
http://www.hrkorea.co.kr
ȸ»çÁÖ¼Ò
[137-861] ¼¿ï ¼Ãʱ¸ ¼ÃÊ2µ¿ 1340-6 ³²°ºôµù 11Ãþ
ÃÖÁ¾¼öÁ¤ÀÏ : 2024³â 04¿ù 18ÀÏ
º» Á¤º¸´Â HRKorea¿¡¼ Á¦°øÇÑ ÀÚ·áÀ̸ç, Æĸ¶¸ÞµðÀâ´Â(Àº) ±âÀçµÈ ³»¿ë¿¡ ´ëÇÑ ¿À·ù¿Í Áö¿¬, »ç¿ëÀÚ°¡ À̸¦ ½Å·ÚÇÏ¿© ÃëÇÑ Á¶Ä¡¿¡ ´ëÇÏ¿© Ã¥ÀÓÀ» ÁöÁö ¾Ê½À´Ï´Ù. º» Á¤º¸´Â Æĸ¶¸ÞµðÀâÀÇ µ¿ÀÇ ¾øÀÌ Àç¹èÆ÷ÇÒ ¼ö ¾ø½À´Ï´Ù.
¼±ÅÃÇϽŠÀ̷¼¿Í ÀÔ·ÂÇϽŠ³»¿ëÀÌ ÇØ´ç¾÷üÀÇ ´ã´çÀÚ¿¡°Ô À̸ÞÀÏ·Î Àü¼ÛµË´Ï´Ù.
Áö¿øÀ̷¼
À̷¼¸¦ ¼±ÅÃÇØÁÖ¼¼¿ä
´ã´çÀÚ¸í
ÃÖ°æ¼÷ (kschoi@hrkorea.co.kr)
º¸³»´Â»ç¶÷
³»¿ë
°³ÀÎÁ¤º¸Ã³¸®¹æħ
|
ȸ¿ø¾à°ü
|
°í°´Áö¿ø¼¾ÅÍ
|
Á¦ÈÞ ¹× ±¤°í¹®ÀÇ
|
´ÙÀÌ·ºÆ®°áÁ¦
¼³¸³ÀÏ : 2015³â 12¿ù 02ÀÏ l °³ÀÎÁ¤º¸Ã¥ÀÓÀÚ : À±º´È£
Á÷¾÷Á¤º¸Á¦°ø»ç¾÷½Å°í¹øÈ£ J150002023003
»ç¾÷ÀÚµî·Ï¹øÈ£ : 285-18-01963
| Åë½ÅÆǸž÷½Å°í : Á¦ 2023-ÀÎõ-0450È£
Copyright ¨Ï
Æĸ¶¸ÞµðÀâ
Co. Ltd. All rights reserved.