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Wir bieten Webinar Aufzeichnungen zu folgenden Themen (in englischer Sprache)

 

The Medical Devices Regulation (MDR)

  • 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)

  • 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

  • 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