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 webinar subjects include

The Medical Devices Regulation (MDR)

  • MDR Rule 14 Devices – conformity assessment process and documentation requirements for submissions
  • MDR lessons learnt
  • Clinical evaluation under the MDR – do you understand the requirements?
  • Hear BSI’s Dr Jayanth Katta talk at the MedTech Digital Week
  • BSI’s perspectives on Article 117 and drug-device combinations
  • MDR - What we currently know
  • Article 120 - What is due in 2020?
  • MDR Conformity Assessment Routes
  • Medicines and Biologics
  • MDR Article 18 Implant Card
  • Update to the regulatory implications of Brexit
  • Medical devices incorporating biological tissue: MDR requirements
  • QMS aspects of the MDR (& IVDR)
  • EU Harmonization – MDR Requirements & progress on key standards & labelling
  • General Safety and Performance Requirements in the New MDR
  • Technical Documentation requirements under MDR, including requirements for legacy files
  • Medical Device Regulation - what you need to know
  • MDR & IVDR - Roles in the regulatory system
  • New version of MEDDEV 2.7.1 Revision 4: Key changes and clarifications

The In Vitro Diagnostic Regulation (IVDR)

  • IVDR Lessons Learnt
  • ISO 20916 IVD — Clinical performance studies
  • Maintaining your CE Certification under the IVDR, a Lifecycle approach
  • Performance Evaluation under the In Vitro Diagnostic Regulation (IVDR) – Part 2
  • Performance Evaluation under the In Vitro Diagnostic Regulation (IVDR) – Part 1
  • Understanding the QMS requirements under the IVD Regulation
  • In Vitro Diagnostic Regulation (IVDR) Conformity Assessment Routes
  • In Vitro Diagnostic Regulation (IVDR) Application Process
  • How ready are you for the IVD Regulation?
  • Update to the regulatory implications of Brexit
  • General Safety and Performance requirements of the IVDR
  • MDR & IVDR - Roles in the regulatory system
  • QMS aspects of the MDR (& IVDR)
  • In Vitro Diagnostic Regulation - what you need to know

QMS, ISO 13485, MDSAP and medical device standards

  • Symbols to be used on labelling (ISO 15223) and information to be provided by the manufacturer (ISO 20417)
  • ISO 14971:2019 Risk Management for Medical Devices
  • Update to the regulatory implications of Brexit
  • QMS aspects of the MDR (& IVDR)
  • EU Harmonization – MDR requirements & progress on key standards & labelling
  • Critical update on Medical Device Single Audit Program (MDSAP): Countdown for Canada
  • Are you ready for the Medical Device Single Audit Program (MDSAP)?
  • New versions of ISO 13485:2016 and ISO 9001:2015
  • ISO 13485:2016 publication

Market access requirements

  • Person Responsible for Regulatory Compliance
  • UKCA for Medical devices and IVDs, are you ready?
  • BSI update on the new UKCA and future UK regulation for Medical Devices and IVDs
  • Post Market Surveillance and Vigilance - do you know the requirements?
  • Usability engineering, a new focus: Do you understand the requirements?
  • Nanomaterials and Medical Device Regulations
  • Validation and Verification, are you clear on the requirements?
  • Electro-Medical Device Market Access: Frequently Asked Questions

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