Medical Devices webinars

Our BSI Technical Specialists address key topics that affect legislation, risk, and regulatory changes. Watch previously recorded webinars, access presentation slides, and request more information by registering for free below.

Watch BSI Medical Devices webinars

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Webinar Subjects

The Medical Devices Regulation (MDR)

MDR Conformity Assessment Routes
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

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

The In Vitro Diagnostic Regulation (IVDR)

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

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)?