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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
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Medical Device and FDA Regulations and Standards News
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M
FDA News
USFDA – Safety and Performance Based Pathway Guidance
Marcelo
Jan 22, 2019
Replies
0
Views
457
Jan 22, 2019
Marcelo
M
Medical Device News
Team-NB publishes a press release regarding the designation process in the framework of the IVDR regulation – Regulation (EU) 2017/746
Marcelo
Jan 22, 2019
Replies
0
Views
372
Jan 22, 2019
Marcelo
M
Informational
Scope of BSI for the MDR – Regulation (EU) 2017/745 on medical devices
Marcelo
Jan 22, 2019
Replies
0
Views
483
Jan 22, 2019
Marcelo
M
Informational
First NB designated to the EU MDR regulation – BSI UK
Marcelo
Jan 21, 2019
Replies
2
Views
549
Jan 21, 2019
Marcelo
M
Medical Device News
EU MDR – Information on stages in designation process from Team-NB
Marcelo
Dec 19, 2018
Replies
5
Views
596
Jan 17, 2019
yodon
M
Informational
BSI – MDR Documentation Submissions Best Practices Guidelines
Marcelo
Jan 17, 2019
Replies
0
Views
1,022
Jan 17, 2019
Marcelo
M
Informational
How To Avoid Compliance & Timeline Risks When Selecting A Medical Device Supplier
Marcelo
Jan 15, 2019
Replies
0
Views
389
Jan 15, 2019
Marcelo
M
Informational
Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House
Marcelo
Jan 15, 2019
Replies
0
Views
570
Jan 15, 2019
Marcelo
M
Medical Device News
Last update of the MDR and IVDR implementing measures rolling plan – December 2018
Marcelo
Jan 14, 2019
Replies
0
Views
451
Jan 14, 2019
Marcelo
M
Informational
EC – Guide for referencing standards in public procurement in Europe (JIS Action 11)
Marcelo
Jan 14, 2019
Replies
0
Views
335
Jan 14, 2019
Marcelo
M
Medical Device News
EC – Commission reply to a Petition “For a Compensation Fund for PIP Breast Implants and CE” from the website change.org
Marcelo
Jan 11, 2019
Replies
0
Views
345
Jan 11, 2019
Marcelo
M
Medical Device News
TGA Consultation: Good Clinical Practice Inspections Program
Marcelo
Jan 11, 2019
Replies
0
Views
299
Jan 11, 2019
Marcelo
M
Medical Device News
Disponibilizados textos das CPs 584, 585 e 585 da ANVISA
Marcelo
Jan 9, 2019
Replies
0
Views
306
Jan 9, 2019
Marcelo
M
Informational
MDDI - It’s Time to Meet the Users of Medical Devices
Marcelo
Jan 9, 2019
Replies
0
Views
304
Jan 9, 2019
Marcelo
M
FDA News
USFDA Digital Health Update – New actions and documents
Marcelo
Jan 8, 2019
Replies
0
Views
331
Jan 8, 2019
Marcelo
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