Designation and monitoring of Notified Bodies
Archives: Downloads
MEDDEV 2.10/2 rev.1 Annex 4
NB selection Attachement 4
Special Rules of Accreditation for Certification Bodies of Quality Systems
scope Sterile Medical Devices
MEDDEV 2.10/2 rev.1 Annex 3
NB selection Attachment 3
Responsibilities of the Notified Body
MEDDEV 2.10/2 rev.1 Annex 2
NB-selection Attachement 2
Example of a training course format
SG4/(00)3 Training Requirements for Auditors
GHTF / IMDRF
Auditing QMS
Part 3:Training Requirements for Auditors
SG2/N008R4 Vigilance Reporting
GHTF
Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical Devices
MEDDEV 2.5/7 rev.1 Breast Implants
Conformity assesment Breast Implants
MEDDEV 2.2/3 rev 3 Use by – date
Essential Requirements
Limitation of safe use
MEDDEV 2.1/5 Measuring function
Medical device
MEDDEV
2.1/5
Measuring function
Measure Measurement
MEDDEV 2.5/3 rev/2 Subcontracting QS
Subcontracting quality systems related