Dispositifs Médicaux - Ressources - Webinars

Webinars dispositifs médicaux en direct et à la demande

Nous offrons une gamme étendue de webinars gratuits et en direct animés par les experts produits BSI sur toutes sortes de sujets qui concernent votre entreprise tels que la législation, le risque et les modifications réglementaires.

Sélectionnez un webinar futur ci-dessous pour faire part de votre intérêt. Vous pouvez aussi visionner tous les webinars précédents enregistrés.

Medical Devices Regulation (MDR)

Annex XVI devices without an intended medical purpose - dermal fillers focused
Devices With No Medical Purpose - MDR annex XVI Devices
Amending Regulation (EU) 2023-607 and possible pitfalls
EU MDR Rule 21 – Key considerations in the Conformity Assessment process
MDR Conformity Assessment Routes in the AIMD space
Extension to the MDR transition timelines
Understanding Periodic Safety Update Reports and submitting to BSI
Preparing a Summary of Safety and Clinical Performance (SSCP)
Preparing a Post Market Clinical Follow Up Plan & Evaluation Report
Preparing a Clinical Evaluation Report (Part 2)
Preparing a Clinical Evaluation Report (Part 1)
Preparing a Clinical Evaluation Plan
Article 54 Understanding the Clinical Evaluation Consultation Process
Post market clinical follow up under MDR
Clinical evaluation for medical software & AI devices
Claiming equivalence under the MDR – regulatory considerations
Understanding Article 61 (10) – When Clinical Data is not deemed appropriate
Well-established technologies - defining the criteria from MDCG 2020-6
AIMDD to MDR transition - what you need to know
Active Implantable Medical Devices under the EU MDR at MedTech Summit 2021
Personalised Medical Devices - what you need to know
The Periodic Safety Update Report (PSUR) & Vigilance under the MDR
MDR Rule 14 Devices – conformity assessment process and documentation requirements for submissions
BSI view on Article 117 and drug-device combinations