Webinare zu Medizinprodukten

Wir bieten ein umfassendes Angebot an kostenfreien Webinaren. Unsere BSI Produktexperten referieren über relevante Themen für Ihr Unternehmen, so zum Beispiel über Gesetzgebung, Risiko und regulatorische Änderungen.

Wählen Sie aus der Liste von aktuellen Webinaren, und melden Sie sich an. Alternativ dazu können Sie sich die Aufzeichnungen von unseren früheren Webinaren ansehen.



Themen der Webinar Aufzeichnungen

Verordnung über Medizinprodukte (Medical Devices Regulation)

  • Post market clinical follow up under MDR
  • Clinical evaluation for medical software & AI devices
  • Claiming equivalence under the MDR – regulatory considerations
  • Understanding Article 61 (10) – When Clinical Data is not deemed appropriate
  • Well-established technologies - defining the criteria from MDCG 2020-6
  • AIMDD to MDR transition - what you need to know
  • Personal Medical Devices - what you need to know
  • The Periodic Safety Update Report (PSUR) & Vigilance under the MDR
  • MDR Rule 14 Devices - conformity assessment process and documentation requirements for submissions
  • Bedeutung der klinischen Prüfung für die MDR
  • MDR Lessons Learnt
  • Technische Dokumentation gemäß MDR - was wir bis jetzt gelernt haben
  • 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

 

Verordnung über In-vitro-Diagnostika (In Vitro Diagnostic Regulation)

  • 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 und Normen für Medizinprodukte 

  • 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

  • Hybrid audits the new way of working post pandemic
  • 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