| 9 |
유럽 |
지침 |
[MDCG 2022-13] Designation, re-assessment and notification of conformity assessment bodies and notified bodies
|
2023-12-19 |
| 8 |
유럽 |
지침 |
[MDCG 2022-4] Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD
|
2023-12-19 |
| 7 |
미국 |
지침 |
FDA_Guidance-ISO 10993-1
|
2023-12-19 |
| 6 |
미국 |
지침 |
FDA_Guidance-Software as a Medical Device(SAMD) - Clinical Evaluation.
|
2023-12-19 |
| 5 |
미국 |
지침 |
FDA_Guidance-Cybersecurity in Medical Devices - RTA
|
2023-12-19 |
| 4 |
미국 |
지침 |
FDA_Guidance-Electronic Submission Template for Medical Device 510(k) Submissions
|
2023-12-19 |
| 3 |
유럽 |
지침 |
MDCG 2023-3, Questions and Answers on vigilance terms and concepts as outlined in the Regulation(EU) 2017/745 on medical devices
|
2023-11-27 |
| 2 |
미국 |
소식지 |
[한국의료기기안전정보원] 2023년 국가별 체외진단의료기기 규제동향 소식지(미국편)
|
2023-07-20 |
| 1 |
유럽 |
소식지 |
[한국의료기기안전정보원] 유럽(CE) 의료기기 MDR 제도 이해 및 대응 전략 보고서
|
2023-07-19 |
