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I webinar del 2017

  • Roles and Responsibilities in the new Medical Device and IVD Regulation - 15 Mar
  • Post Market Surveillance and Vigilance - do you know the requirements? - 22 Feb

I webinar del 2016

  • 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
  • Medical Device Single Audit Program (MDSAP) for Manufacturers update - 18 Feb
  • The growing role of usability engineering for medical devices - 13 Jan

I webinar del 2015

  • An update on the published FDIS of ISO 13485 - 02 Dec
  • Medical Device Software - do you understand how software is regulated? - 20 Nov
  • ASEAN Medical Device Directive (AMDD) A brief Overview - 11 Nov
  • You have launched your product, do you know your responsibilities now? 13 Oct
  • MDR product reclassification 09 Sept
  • ISO 13485 and ISO 9001 update 28 July
  • Clinical evaluation, clinical investigations, do you have enough evidence? - 7 July
  • Requirements for a 'Person Responsible for Regulatory Compliance' - 23 June
  • ISO 13485 The New Revision - 19 May
  • IVD Field Safety Notices - 23 March
  • Unannounced Audits Lessons Learnt - 17 March
  • MDD regulatory update - 05 March
  • Japan PMD Act - 19 Feb
  • Medical Device Single Audit Program - 20 Jan

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