Webinar sui dispositivi medici

Webinar sui dispositivi medici

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Webinar sui dispositivi medici
Webinar sui dispositivi medici
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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.

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Medical Devices Regulation (MDR)

  • Medical Device software under MDR - Perspectives from a Notified Body
  • 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
  • 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

 

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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
  • 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

 

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Acceso ai mercati e ISO 13485

  • Prepare for the new Post-market Surveillance Requirements in Great Britain
  • PFAS phase out and their impact on Medical Devices
  • AAI Algorithm Auditing and Dataset Testing (AA&DT) for the Medical Imaging Industry
  • 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: 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