Medical device webinars

Medical device webinars

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Medical device webinars
Medical device webinars
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Medical device live and on demand webinars

We offer a wide range of free and live webinars hosted by BSI Technical Specialists addressing key topics that affect your business including legislation, risk, and regulatory changes.

Select an upcoming webinar below to register your interest. Alternatively you can watch all of our on-demand webinars below.

On demand webinars

If this is your first time accessing our on demand webinars, you will need to register using the form below.

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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
  • In Vitro Diagnostic Regulation (IVDR) Application Process

 

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Market access and 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 - 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?
  • New versions of ISO 13485:2016 and ISO 9001:2015