Search the Elsmar Cove!
**Search ALL of Elsmar.com** with DuckDuckGo including content not in the forum - Search results with No ads.

Medical Device and FDA Regulations and Standards News

Marcelo follows sandards closely. A link to his website is in all the threads he has posted in this forum. If you like, you can post Medical Device and FDA Regulations and Standards News, too. Just start a New Discussion (thread).

Discussions
Marcelo Antunes
Informational TGA – Essential principles checklist (medical devices)
Replies
1
Views
42
jkuil
Marcelo Antunes
Informational How to perform a clinical evaluation of medical devices – Part 1 – Overview and sample of activities
Replies
0
Views
159
Marcelo Antunes
Marcelo Antunes
Informational US FDA Final Guidance – Special Premarket Notification [510(k)] Pathway
Replies
0
Views
31
Marcelo Antunes
Marcelo Antunes
Informational From RAPS – Novartis Inhaler is First Device to be Certified Under MDR
Replies
0
Views
42
Marcelo Antunes
Marcelo Antunes
Informational EU – Commission Implementing Decision (EU) as regards the designation of expert panels in the field of medical devices
Replies
0
Views
31
Marcelo Antunes
Marcelo Antunes
Informational US FDA Patient Engagement Advisory Committee – Cybersecurity in Medical Devices: Communication That Empowers Patients
Replies
0
Views
24
Marcelo Antunes
Marcelo Antunes
Informational TGA – Webinar: The cybersecurity of medical devices
Replies
0
Views
27
Marcelo Antunes
Marcelo Antunes
Informational Paper on open access – EU postmarket surveillance plans for medical devices
Replies
1
Views
213
vidhya
Marcelo Antunes
Informational BSI certifies first product to the Medical Devices Regulation
2
Replies
10
Views
309
Marcelo Antunes
Marcelo Antunes
Medical Device News EU – Transition Timelines from the Directives to the Regulations – Medical Devices and in vitro Diagnostic Medical Devices
2
Replies
10
Views
640
nancy
Marcelo Antunes
Informational Final guidance – GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carc
Replies
0
Views
57
Marcelo Antunes
Marcelo Antunes
Informational US FDA Final Guidance – Acceptance Review for De Novo Classification Requests
Replies
1
Views
46
Adacus
Marcelo Antunes
Informational FDA discussion paper – Consideration of Benefit-Risk Approaches for Weight-Loss Devices
Replies
0
Views
43
Marcelo Antunes
Marcelo Antunes
Informational US FDA Final Guidance – Humanitarian Device Exemption (HDE) Program
Replies
0
Views
38
Marcelo Antunes
Marcelo Antunes
Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs
Replies
1
Views
51
Ronen E
You must log in or register to post here.
Top Bottom