Go to Page # Page of 45
loading

MDR Designation Process of Notified Bodies

 Andrea Johmann PhD
  18th-Oct-2018
Description: Review the assessments by NB of manufacturers´ technical documentation, in particular clinical evaluatiion documentation
Views: 2560
weSRCH App on Apple
Contents:
Designation Process of Notified Bodies

Dr Andrea Johmann

LSA2018 - Lübeck Summer Academy on Medical Technology
Regulatory Affairs
04.07.2018

Content of the presentation
Designation process under the „old“ system
Designation process under MDR
CAB´s application
scope
pre-assessment and off-site activities
on-site assessment
post-assessment activities
decision on designatio ... See more

Recent Presentations

...
17 September, 2019

IMAP Medical Devices

Here describe the IMAP’s experience in healthcare buy-side advisory and deep knowledge of the industry were key factors in successfully closing the transaction.

IMAP
16 September, 2019
PFCD
15 September, 2019