Duration: (1:31:28) ?Subscribe5835 2025-02-13T04:15:41+00:00
第一讲:详解FDA 510(k)申报[FDA中级医疗器械注册专员课堂]
(1:31:28)
第二讲:详解FDA 特殊510k 申报程序 [FDA中级医疗器械注册专员课堂]
(1:10:28)
第五讲:详解FDA 510(K)变更[FDA中级医疗器械注册专员课堂]
(1:22:46)
第六讲:详解FDA创新器械申报途径——De Novo申报[FDA 中级医疗器械注册专员课堂]
(1:30:16)
第46期 什么是RMD?第一次领取RMD的准确日期;RMD的计算方式;RMD的合并规则;怎样最大限度减低RMD金额?
(15:2)
Mastering your 510(k) submission process
(1:6:28)
How to prepare an FDA eSTAR 510(k) submission
(38:26)
Master Class - FDA Pre-Submissions
(1:4:20)
Using the new eSTAR templates for a 510(k) submission and the FDA eSTAR draft guidance
(37:47)
Cybersecurity Webinar - Learn what the FDA wants in your 510(k)
(1:8:44)
Software Validation Documentation for FDA 510(k) pre-market notification submission
(1:36:15)
[2022년 해외 수출국 최신 규제 전문가 세미나] 02. 미국 인증 FDA(510K) 인허가 대응방안
(1:59:24)
FDA Process for Medical Device Startups: an Investor's Point of View
(56:55)
What do you want to know about the FDA 510(k) process?
(17)
Master the FDA 510(k) Process in Minutes!
(45)
AVATAR MEDICAL has received FDA 510(k) clearance for its VR surgical planning solution
(54)
What do FDA reviewers look for in 510 (k) and IDE submissions?
(2:41)
How to Get FDA 510(k) Clearance? | Medical Device Submission Guide | Intro Video
(8:8)
510(k) Exemptions
(12)
Understanding the FDA Medical Device 510k Process
(2:19)
510(k) eSTAR Webinar - Indications for Use and Classification
(19:8)
US FDA 510K Certification | Shamkris Group
(2:23)
510(k) Tip - Standards you need for medical device labeling - links in the description
(16)
510(k) tip - make sure you are signed up for email notifications of new FDA guidance documents
(53)
510(k) Tip - When do you submit a 510(k)?
(1:)
Help EVERY population access the medical care they need! #fda #medicaldevice #healthcare
(27)
US FDA 510(k) Clearance \u0026 Premarket approval-Operon Strategist
510(k) Tip - Get purchasing involved sooner