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GMED North America @UCSB9OGad8NAq5t8QQ2Ub9-g@youtube.com

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Notified body established in France since 1901. We serve the


01:40
Video MDR Training
01:11
GMED New Year 2021
49:27
E-health technologies in Medical Devices: key development milestones and regulatory constraints
44:09
Biocompatibilité
28:22
Biocompatibility: How to demonstrate the control of the biological risk
16:29
Stepping into MDSAP
28:18
CE Marking of Medical Devices - Technical Documentation
29:53
IVD European Regulation: how QMS requirements interacts with ISO 13485:2016
30:25
Medical Device Usability: Highlights of European Regulations and the Latest Standards
18:40
Post Market Surveillance requirements under the new European Medical Device Regulations
16:11
Control of Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives
43:05
Medical Device & IVD regulations, impacts for MD manufacturers
12:48
Notification of changes: How, what and when to communicate with your Notified Body?
15:18
Initial Certification Audit: Common Pitfalls for Medical Device Manufacturers
28:25
MEDDEV 2.7.1 Rev 4: New Requirements and Changes for Clinical Evaluation Reports (CER)
16:11
Embedded Software in Medical Device : Common Regulatory and Quality pitfalls
22:02
Clinical and Performance evidence requirements in the future EU IVD Regulation
12:52
Impact of Critical Suppliers and Subcontractors on Medical Device Market Approvals
22:13
Evolution of ISO 13485:2016 and ISO 9001:2015 standards
32:17
Medical Device Compliance during Merger and Acquisition and the role of Notified Bodies
16:51
Upcoming revisions of EU regulations & the reclassification of In Vitro Diagnostics
24:34
Reclassification of Medical Devices, upcoming revisions of EU regulations
25:10
Recent EU Medical Device Regulatory Evolutions: Moving Forward
27:21
Medical Devices Containing Ancillary Medicinal Substances
16:37
The IVD Directive and borderline products
58:04
Russia Medical Device Market Access, ISO 13485, and CE Marking for Medical Device Manufacturers
14:10
Sampling Medical Devices for Testing during Unannounced Audits
24:46
CE Marking and the Roles of Notified Bodies
19:41
INMETRO Certification
40:46
Mexico Medical Device Market Access and ISO 13485 certification
19:34
Stand-alone software classification & regulation in Europe
23:34
CE Marking Around the World: How to Enhance the Achievements of the CE Marking to Open More Markets
22:17
Transfer notified body
45:26
The Clinical Evaluation Demonstration of clinical safety and performance
28:40
IVD Technical File Compilation
30:46
Evolutions in the EU IVD Regulatory Framework
21:05
Understanding ISO 14971 2012
30:24
FREE WEBINAR Controlling Critical Subcontractors in 2014
25:37
Free Webinar ISO 14971:2012
58:26
FREE WEBINAR Future of the IVD Directive: Expected Regulatory Change Based on European Commission