| 12 |
유럽 |
지침 |
Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V2.
|
2023-12-19 |
| 11 |
유럽 |
지침 |
[MDCG 2023-3] Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices
|
2023-12-19 |
| 10 |
유럽 |
지침 |
[MDCG 2022-14] Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs
|
2023-12-19 |
| 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 |
