Medical Device Webinars

We offer a wide range of free webinars hosted by BSI product experts 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 previously recorded webinars below.

For upcoming events click here.

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Medical Devices Regulation (MDR)

  • MDR Annex XVI: Devices without an intended medical purpose
  • 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
  • Amending Regulation (EU) 2023/607 and possible pitfalls

 

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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 In Vitro Diagnostics (IVD) Kits
  • Maintaining Compliance: IVDR post-certification activities
  • Extension to IVDR transition timelines
  • 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
  • Navigating your IVDR certification process for CE marking

 

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Market access and ISO 13485

  • 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?

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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