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)

  • 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
  • MDR lessons learnt
  • Clinical evaluation under the MDR – the requirements?
  • BSI view on Article 117 and drug-device combinations
  • MDR - What we currently know
  • MDR Conformity Assessment Routes



In Vitro Diagnostic Regulation (IVDR)

  • IVDR Regulatory updates
  • Understanding IVDR Software and Cybersecurity
  • IVDR Companion Diagnostics (CDx) Update
  • Pathways to IVDR compliance
  • Navigating the complex IVDR landscape
  • IVDR Lessons Learnt
  • ISO 20916 IVD — Clinical performance studies
  • Performance Evaluation under the IVDR – Part 2
  • Performance Evaluation under the IVDR – Part 1
  • Understanding the QMS requirements under the IVDR
  • In Vitro Diagnostic Regulation (IVDR) Application Process



Market access and ISO 13485

  • Shaping Trust in AI: Understanding 42001 Standard
  • EU AI Act Explained - Navigating the legislation with BSI
  • Hybrid audits the new way of working post pandemic
  • UKCA Medical Devices - are you ready for the future?
  • Person Responsible for Regulatory Compliance
  • UKCA for Medical devices and IVDs, are you ready?
  • New versions of ISO 13485:2016 and ISO 9001:2015