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 previously recorded webinars below.

Listen back to our webinars

If this is your first time watching our webinars you will need to register using the form below.

Webinar subjects include

The Medical Devices Regulation (MDR)

  • 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 (Sept 2018)
  • What are the regulatory implications of Brexit? (May 2018)
  • 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
  • Roles and responsibilities in the Medical Device and IVD Regulations

 

The In Vitro Diagnostic Regulation (IVDR)

  • How ready are you for the IVD Regulation?
  • Update to the regulatory implications of Brexit
  • The regulatory implications of Brexit
  • General Safety and Performance requirements of the IVDR
  • Roles and Responsibilities in the MDR and IVDR
  • QMS aspects of the MDR (& IVDR)

QMS, ISO 13485 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
  • QMS aspects of the MDR (& IVDR)
  • EU Harmonization – MDR requirements & progress on key standards & labelling
  • New versions of ISO 13485:2016 and ISO 9001:2015
  • ISO 13485:2016 publication

 

The Medical Device Single Audit Program (MDSAP)

  • Critical update on Medical Device Single Audit Program (MDSAP): Countdown for Canada
  • Are you ready for the Medical Device Single Audit Program (MDSAP)?

 

Market access requirements

  • 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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