Medical Devices webinars

The Medical Devices Regulation (MDR)

  • MDR Conformity Assessments Routes
  • MDR Article 18 Implant Card
  • Update to the regulatory implications of Brexit (Sept 2018)
  • QMS aspects of the MDR (& IVDR)
  • EU Harmonization - MDR Requirements & progress on key standards & labeling
  • 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)

  • Performance Evaluation under the In Vitro Diagnostic Regulation (IVDR) - Part 1
  • 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
  • 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)
  • Understanding the QMS requirements under the IVD Regulation

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