Votre événement devrait être ici ! Pour référencer, gérer, promouvoir... Pour s'informer ou se former ... Inscriptions en ligne

Langue du site : Français - English
Réf : 28915
Evènement :EU Medical Device Regulation (MDR) – Updated CE Marking Process and ISO 13485:2016 Expectations

Date :Mardi 19 Février 2019

Lieu :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, California, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

Editorial

This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU. It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016.

Objectives

Upon completion of this course, attendees will have enhanced knowledge of the ever-changing landscape of Medical Device Regulation in the EU. The content of this course is designed to simplify the understanding of requirements and to provide attendees with the latest insight on how changes are being viewed and implemented by companies marketing products in the EU.

Program

  • EU Regulatory and Legislative Structure
  • EU Definition of a Medical Device
  • 3 EU Directives -> 2 EU Regulations
  • Key Agencies Involved
  • Why the change from Directives to Regulations?
  • Overview of CE Marking Process & Changes Resulting from the EU MDR
  • Updated Role of the Notified Body
  • Medical Device Classifications
  • Essential Requirements -> Safety & Performance Requirements
  • Integration of Risk Assessment / Risk Management
  • Conformity assessment
  • Device Vigilance & Reporting System
  • MDR Overview (by Article & Annex)
  • ISO 13485:2016 Updates
  • Medical Device Single Audit Program (MDSAP)
  • Global Impact of ISO 13485:2016 Certification and CE Marking
  • Tips on Working with Regulatory Authorities

Lieu

Plan et itinéraire
Adresse de la conférence :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
California, États-Unis
Tél : +1-888-717-2436
Plan et itinéraire

Renseignements

Pour accéder aux informations vous devez être connecté. Créer un compte est facile et gratuit!

Connexion à votre compte
S'inscrire sur Doctorama

Précisions

EU Medical Device Regulation (MDR) – Updated CE Marking Process and ISO 13485:2016 Expectations Management
eu medical device regulation, eu ce marking, eu mdr, eu mdr update, eu mdr changes, eu mdr training, eu medical device registration, eu medical device directive
Professionnels, Executive Management Quality Assurance Regulatory Affairs Clinical research and medical operations Product Development Manufacturing / Distribution Medical Device R&D Clinical trial supply CROs
10 -- --
English

Divers

Pour plus d'informations sur EU Medical Device Regulation (MDR) – Updated CE Marking Process and ISO 13485:2016 Expectations, veuillez contacter ComplianceOnline

Pour afficher le site de l'annonceur, obtenir une lettre d'invitation, vous devez être connecté

Connexion à votre compte
S'inscrire sur Doctorama


Recommander cet évènement