Webinar sui dispositivi medici

Webinar sui dispositivi medici

Red Overlay
Webinar sui dispositivi medici
Webinar sui dispositivi medici
Red Overlay

Webinar, in diretta e on demand, dedicati ai dispositivi medici

Offriamo una vasta gamma di live webinar gratuiti, tenuti da esperti BSI di prodotto, che trattano argomenti chiave come la legislazione, il rischio e modifiche normative che influenzano il tuo business.

Seleziona di seguito il webinar cui vuoi partecipare e registrati.
È possibile guardare tutti i nostri webinar registrati in precedenza.

Prossimi webinar gratuiti

Clicca sul titolo del webinar per avere ulteriori informazioni e per registrarti. Dopo l'evento a tutti i partecipanti verrà inviato un link al webinar registrato e alle slide presentate.

IVDR Regulatory updates

Data: 28 novembre 2023

Orario: 09:00 - 10:00 e 16:00 - 17:00 BST

Lingua: inglese

 

Shaping Trust in AI: Understanding 42001 Standard

Data: 5 dicembre 2023

Orario: 09:00 - 10:00 e 16:00 - 17:00 BST

Lingua: inglese

Archivio dei webinar passati

Compilando il modulo sottostante puoi rivedere i nostri webinar passati.


/globalassets/meddev/localfiles/en-gb/images/375x275/mdr1-375-275.jpg

Medical Devices Regulation (MDR)

  • 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

 

/globalassets/meddev/localfiles/en-gb/images/375x275/ivdr1-375-275.jpg

In Vitro Diagnostic Regulation (IVDR)

  • 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

 

/globalassets/meddev/localfiles/en-gb/images/375x275/market-access-375-275.jpg

Acceso ai mercati e ISO 13485

  • 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