Brexit : Quelles conséquences pour vos produits marqués CE
GMED
Brexit : Quelles conséquences pour vos produits marqués CE
49:59
MDSAP Transfer
GMED
MDSAP Transfer
0:07
Streamline Your Pathway
GMED
Streamline Your Pathway
0:04
Trust Our Team
GMED
Trust Our Team
0:04
IVDR Upcoming Changes w Tom Patten
GMED
IVDR Upcoming Changes w Tom Patten
4:48
Happy New Year 2025
GMED
Happy New Year 2025
0:30
Video MDR Training
GMED
Video MDR Training
1:40
GMED New Year 2021
GMED
GMED New Year 2021
1:11
E-health technologies in Medical Devices: key development milestones and regulatory constraints
GMED
E-health technologies in Medical Devices: key development milestones and regulatory constraints
49:27
Biocompatibilité
GMED
Biocompatibilité
44:09
Biocompatibility: How to demonstrate the control of the biological risk
GMED
Biocompatibility: How to demonstrate the control of the biological risk
28:22
Stepping into MDSAP
GMED
Stepping into MDSAP
16:29
CE Marking of Medical Devices - Technical Documentation
GMED
CE Marking of Medical Devices - Technical Documentation
28:18
IVD European Regulation: how QMS requirements interacts with ISO 13485:2016
GMED
IVD European Regulation: how QMS requirements interacts with ISO 13485:2016
29:53
Medical Device Usability: Highlights of European Regulations and the Latest Standards
GMED
Medical Device Usability: Highlights of European Regulations and the Latest Standards
30:25
Post Market Surveillance requirements under the new European Medical Device Regulations
GMED
Post Market Surveillance requirements under the new European Medical Device Regulations
18:40
Control of Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives
GMED
Control of Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives
16:11
Medical Device & IVD regulations, impacts for MD manufacturers
GMED
Medical Device & IVD regulations, impacts for MD manufacturers
43:05
Notification of changes: How, what and when to communicate with your Notified Body?
GMED
Notification of changes: How, what and when to communicate with your Notified Body?
12:48
Initial Certification Audit: Common Pitfalls for Medical Device Manufacturers
GMED
Initial Certification Audit: Common Pitfalls for Medical Device Manufacturers
15:18
MEDDEV 2.7.1 Rev 4: New Requirements and Changes for Clinical Evaluation Reports (CER)
GMED
MEDDEV 2.7.1 Rev 4: New Requirements and Changes for Clinical Evaluation Reports (CER)
28:25
Embedded Software in Medical Device : Common Regulatory and Quality pitfalls
GMED
Embedded Software in Medical Device : Common Regulatory and Quality pitfalls
16:11
Clinical and Performance evidence requirements in the future EU IVD Regulation
GMED
Clinical and Performance evidence requirements in the future EU IVD Regulation
22:02
Impact of Critical Suppliers and Subcontractors on Medical Device Market Approvals
GMED
Impact of Critical Suppliers and Subcontractors on Medical Device Market Approvals
12:52
Evolution of ISO 13485:2016 and ISO 9001:2015 standards
GMED
Evolution of ISO 13485:2016 and ISO 9001:2015 standards
22:13
Medical Device Compliance during Merger and Acquisition and the role of Notified Bodies
GMED
Medical Device Compliance during Merger and Acquisition and the role of Notified Bodies
32:17
Upcoming revisions of EU regulations & the reclassification of In Vitro Diagnostics
GMED
Upcoming revisions of EU regulations & the reclassification of In Vitro Diagnostics
16:51
Reclassification of Medical Devices, upcoming revisions of EU regulations
GMED
Reclassification of Medical Devices, upcoming revisions of EU regulations
24:34
Recent EU Medical Device Regulatory Evolutions: Moving Forward
GMED
Recent EU Medical Device Regulatory Evolutions: Moving Forward
25:10
Medical Devices Containing Ancillary Medicinal Substances
GMED
Medical Devices Containing Ancillary Medicinal Substances
27:21
The IVD Directive and borderline products
GMED
The IVD Directive and borderline products
16:37
Russia Medical Device Market Access, ISO 13485, and CE Marking for Medical Device Manufacturers
GMED
Russia Medical Device Market Access, ISO 13485, and CE Marking for Medical Device Manufacturers
58:04
Sampling Medical Devices for Testing during Unannounced Audits
GMED
Sampling Medical Devices for Testing during Unannounced Audits
14:10
CE Marking and the Roles of Notified Bodies
GMED
CE Marking and the Roles of Notified Bodies
24:46
INMETRO Certification
GMED
INMETRO Certification
19:41
Mexico Medical Device Market Access and ISO 13485 certification
GMED
Mexico Medical Device Market Access and ISO 13485 certification
40:46
Stand-alone software classification & regulation in Europe
GMED
Stand-alone software classification & regulation in Europe
19:34
CE Marking Around the World: How to Enhance the Achievements of the CE Marking to Open More Markets
GMED
CE Marking Around the World: How to Enhance the Achievements of the CE Marking to Open More Markets
23:34
Transfer notified body
GMED
Transfer notified body
22:17
The Clinical Evaluation Demonstration of clinical safety and performance
GMED
The Clinical Evaluation Demonstration of clinical safety and performance
45:26
IVD Technical File Compilation
GMED
IVD Technical File Compilation
28:40
Evolutions in the EU IVD Regulatory Framework
GMED
Evolutions in the EU IVD Regulatory Framework
30:46
Understanding ISO 14971 2012
GMED
Understanding ISO 14971 2012
21:05
FREE WEBINAR Controlling Critical Subcontractors in 2014
GMED
FREE WEBINAR Controlling Critical Subcontractors in 2014
30:24
Free Webinar ISO 14971:2012
GMED
Free Webinar ISO 14971:2012
25:37
FREE WEBINAR Future of the IVD Directive: Expected Regulatory Change Based on European Commission
GMED
FREE WEBINAR Future of the IVD Directive: Expected Regulatory Change Based on European Commission
58:26