11-12th November 2020 | Online Event >> Download the full programme to see our line-up of expert speakers and topic sessions.Join us to:
Download the sample attendee list to see who you could meet at Global UDI and Master Data Forum! Preview of accounts: Acsensia Diabetes CareAgfa Allergan ArthrexPreview of job titles: Analyst, Project Management Assoc. Dir. Packaging Technology CEO Deputy Director Medical Device Vigilance, Global Pharmacovigilance
Ahead of this years European UDI's Forum we sat down with Dr. Hajo Reißmann, Head of Medical Supply Controlling at the University Medical Center Schleswig Holstein, who has been running a UDI pilot project, to find out what UDIs truly mean for hospitals. In this report they will discuss:What the...
With Europe facing rapidly-approaching new UDI regulations, plans need to be put in place now in order to meet the deadlines, but the requirements from authorities are not yet clear, therefore manufacturers are unable to commit to costly projects. The question on medical device manufacturers’ minds is – what can...
Organisations of all sizes are recognising the critical role of data quality in information governance and stewardship driven by broader enterprise information management initiatives. Pharma IQ surveyed leading industry professionals on their challenges and investment plans for building a master data management (MDM) strategy to enable global compliance. The results...
Complying with international requirements and standards to ensure global UDI compliance is a key challenge for medical device manufacturers. Contending with changing deadlines and often ambiguous guidelines, manufacturers are looking for clarity from regulators on what exactly is required of them. In light of this and the delay to EUDAMED,...
While UDI (Unique Device Identification) regulations support patient care objectives, many hospitals don’t yet know how to implement this requirement, which can hinder the progression to track information of a specific product. With a view to ensure hospitals are continuing to make headway to overcome these implementation roadblocks, Pharma IQ...
The European Commission recently announced a two-year delay for the launch of the new version of European Database on Medical Devices (EUDAMED) being built to support the European Medical Device Regulation (MDR) including the module that will hold unique device identifiers (UDIs) and other required data on medical devices.In a...
Ahead of this years European UDI forum, Dawn Fowler, Director of UDI and Master Data Management, Masimo and Pharma IQ wrote a report on data management and UDI’s. In this report they will discuss:The transition from GUDID to EUDAMED for FDA-compliant manufacturersBuilding a robust UDI MDM infrastructureWhat are the next...
As the date of application of the EU MDR remains May 26, 2020, the European Commission officially stated that EUDAMED’s launch will be delayed to the date of application for in-vitro medical devices in May 2022. Therefore is there any need to care about UDI for now anymore? In the...