Informationscenter der EU zur Medizinprodukteverordnung | SGS Switzerland

Literaturhinweise:

MDR Unannounced Audit Questionnaire

Medical Device Questionnaire

Medical Device Regulation (MDR) Conformity Assessment Explained

Medical Device Regulation (MDR) Readiness Checklist

Medical Device Regulation (MDR) Technical Documentation Request Form

Medical Devices Notification of Changes, Regulatory Action, Consultancy or Services Rendered

Medical Devices Pre-Audit Client Questionnaire

Notified Body Managers' Declaration of Interest

Product Medical Device Questionnaire

Relevant Subcontractors and Suppliers List

SGS MDR Transition Plan Template

Transition Guidance for SGS Customers

Externe Dokumente

EUDAMED - Actor Registration Factsheet

Factsheet for Manufacturers of In Vitro Diagnostic Medical Devices

Factsheet for Manufacturers of Medical Devices

Factsheet - Medical Devices and in vitro Diagnostic Medical Devices (For Authorised Representatives, Importers and Distributors)

Factsheet on Medical Devices and in vitro Diagnostic Medical Devices (For non-EU/EEA States)

Guidance for Actor Registration Module in EUDAMED (V1 -Sept. 2020)

Implementation for Medical Devices Regulation (Focus on Manufacturer’s obligations)

Implementation Model for In-Vitro Diagnostic Medical Devices Regulation

Implementation Model for Medical Devices Regulation

MDR IVDR Infographic

Transition Timelines from the Directives to the Regulations

Kontakt

SGS - Switzerland - Baar

+41 22 739 91 11

Zugerstrasse 57,

6340, Baar, Schweiz