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

In Vitro Diagnostic Regulation (IVDR)

Rollout of EU Reference Laboratories for IVDR Class D devices
Understanding and meeting the EU IVDR requirements for IVD Kits
IVDR Post-Certification Activities
Shaping Trust in AI with IVD
Extension to IVDR transition timelines
Navigating your IVDR certification process for CE marking
IVDR Regulatory updates
Understanding IVDR Software and Cybersecurity
IVDR Companion Diagnostics (CDx) Update
Pathways to IVDR compliance
Navigating the complex IVDR landscape
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

Market access and ISO 13485

Article 16(4) Certification Scheme requirements
Implement ISO 42001 – Demonstrate a commitment to ethical and responsible AI use
Best Practice for Periodic Safety Update Report (PSUR's)
Prepare for ISO 42001 – a framework for the management of AI
Clinical Evaluation of Orphan Devices & MDCG 2024-10
Renewal under UK and EU Legislations for MDR, IVDR and UKCA
ISO 13485: A Beginners Guide
BSI Notified Approved Body & The Role It Plays In Patient Safety
Shaping Trust in AI - A global perspective on the impact of the EU AI Act
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?