11-12th November 2020 | Online Event >> Download the full programme to see our line-up of expert speakers and topic sessions.Join us to:
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In this report they will discuss:
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 we safely be doing right now, to best set ourselves up for the upcoming regulations?
In light of this, Pharma IQ moderated a roundtable conversation between three UDI experts, Tommy Røsholt, Contracting Project Manager for UDI compliance at Oticon, Tom Jones, UDI Program Director for Johnson & Johnson Supply Chain, and Jenny Young, Contact Project Manager MDR at Convatec.
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 have been presented in
the following infographic to ensure your data is consistent, secure and
compliant.
Download the infographic now >>
Other key
benefits of downloading the infographic:
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, Pharma IQ have created a post-show report highlighting the most exciting takeaways from the 2019 Global UDI and Master Data Forum.
Download the full report now >>
Other key benefits of downloading the report:
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 has created a guidebook of the collated lessons learned by hospitals during the implementation of UDIs for medical devices. The guidebook also analyses how the conduct of manufacturers and hospitals can be altered to optimise the rollout of a project and avoid incurring any detriment.
Download the guidebook now >>
Other key benefits of downloading the guidebook:
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 healthcare purchasing news article, Karen Conway, Vice President, Healthcare Value, GHX, responds to the state of regulatory unreadiness by offering standard practice solutions to prepare for EUDAMED, and improve transparency and coordination of information regarding medical device availability in the EU market.
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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:
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 following article, Patrick Pfau, co-founder of p36 explains why UDI will still be necessary considering the
requirements of EU MDR and how to overcome upcoming challenges related to UDI.