Seminarios online

Ofrecemos una amplia gama de seminarios web gratuitos organizados por profesionales de BSI expertos en producto. Éstos abordan temas clave que afectan a su negocio, incluyendo legislación, riesgos y cambios normativos.

Regístrese en nuestro próximo seminario o vuelva a ver cualquiera de los anteriores.


2018

  • What are the regulatory implications of Brexit?  - 23 May     
  • QMS Aspects of the MDR and IVDR - 27 Feb
  • European Harmonization - MDR Requirements and Progress on key Standards and Labelling - 23 Ene 

2017

  • General Safety and Performance Requirements in the New MDR - 29 Nov
  • Critical update on Medical Device Single Audit Program (MDSAP): Countdown for Canada - 16 Nov
  • Technical Documentation requirements under MDR, including requirements for your legacy files - 30 Oct
  • Usability engineering, a new focus: Do you understand the requirements? - 12 Oct
  • Medical devices incorporating biological tissue: MDR requirements - 25 Jul
  • General Safety and Performance requirements of the IVDR - 12 Jul
  • Electro-Medical Device Market Access: Frequently Asked Questions - 06 Apr
  • Roles and responsibilities in the Medical Device and IVD Regulations - 15 Mar
  • Post Market Surveillance and Vigilance - do you know the requirements? - 22 Feb

2016

  • Implications of the new MDR from a product testing and certification perspective - 01 Dec
  • Nanomaterials: medical devices, regulations and standards - 30 Nov 
  • Are you ready for the Medical Device Single Audit Program (MDSAP)? - 15 Nov
  • Validation and Verification, are you clear on the requirements? - 09 Nov
  • New version of MEDDEV 2.7.1 Revision 4: Key changes and clarifications - 18 Oct
  • ISO 13485:2016, the Medical Device Regulation (MDR) and the IVD Regulation (IVDR) - Are they aligned? - 06 Oct
  • The role of the 'Person Responsible for Regulatory Compliance' in the future Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) - 28 Sept
  • In Vitro Diagnostic Regulation (IVDR) - Changes to the IVD regulatory landscape - 09 Aug
  • Medical Device Regulation (MDR) - Impact on manufacturer resources - 26 Jul
  • The future of standards in Europe - harmonization and other recognition of standards - 04 May
  • Update: Proposed Medical Device Regulations (MDR) - 14 Apr
  • New versions of ISO 13485 and ISO 9001, what do you need to consider? - 23 Mar
  • Publication of the Medical Device International Standard, ISO 13485 - 09 Mar
  • Explanation of MDSAP for Manufacturers - 18 Feb
  • The growing role of usability engineering for medical devices - 13 Jan

2015

  • Medical Device Software - do you understand how software is regulated? - 20 Nov
  • ASEAN Medical Device Directive (AMDD) A brief Overview - 11 Nov
  • MDR product reclassification - 09 Sept
  • IVD Field Safety Notices - 23 March
  • Unannounced Audits Lessons Learnt - 17 March
  • Japan PMD Act - 19 Feb