Previously recorded webinars To view our previously recorded webinars please click on a webinar title below. If this is your first time watching our webinars you will need to register. 2018 What are the regulatory implications of Brexit? European Harmonization - MDR Requirements and Progress on key Standards and Labelling 2017 Medical devices incorporating biological tissue: MDR requirements General Safety and Performance requirements of the IVDR Medical Device Market Access - Frequently Asked Questions Roles and responsibilities in the Medical Device and IVD Regulations Post Market Surveillance and Vigilance - do you know the requirements? 2016 Post Market Surveillance and Vigilance - do you know the requirements? Are you prepared for the Medical Device Single Audit Program (MDSAP)? New version of MEDDEV 2.7.1 Revision 4: Key changes and clarification ISO 13485:2016, the Medical Device Regulation and the IVD Regulation - Are they aligned? The role of the 'Person Responsible for Regulatory Compliance' in the future Medical Device Regulation and In Vitro Diagnostic Device Regulation The In Vitro Diagnostic Regulation - Changes to the IVD regulatory landscape Medical Device Regulation - Implications on manufacturers resources The Future of Standards in Europe - harmonization and other recognitions of standards Update: Proposed European Union Medical Device Regulations New versions of ISO 13485 and ISO 9001, what do you need to consider? Publication of the Medical Device International Standard, ISO 13485 The growing role of usability engineering for medical devices Medical Device Single Audit Program (MDSAP) for Manufacturers 2015 Medical Device Software - do you understand how software is regulated? ASEAN Medical Device Directive - A brief Overview Will your product be reclassified under the new MDR? Medical Device Unannounced Audits Lessons Learned Japanese Pharmaceutical and Medical Device Act (PMD Act) Regulation
