Europe's Dedicated Healthcare UDI Conference
Strengthening Your Regulatory Infrastructure and Improving Your Competitive Edge in the Medical Device Industry
**UPDATE APRIL 5TH 2017** - European Commission adopts new regulations - the European UDI framework is approved!
The EU Commission has now officially voted on and approved the new MDR, replacing the 2012 Medical Device Directive in Europe. With it come many regulatory updates - including the adoption of an FDA-like European UDI system, with a 2020 implementation deadline.
We have repeatedly seen from the FDA-driven US UDI adoption that the implementation process can take a long time, depending on company size and their existing UDI maturity - from auditing oneself to identify both compliance gaps and business opportunities regarding UDIs, through tendering for hardware, software and pastoral solutions, to actually rolling these solutions out across all manufacturing sites and company-wide database systems.
The only way to get ahead of this, to avoid both implentation pitfalls and financial or legal penalties associated with missing the deadline, is to start now. And what better way than Europe's single best 'one-stop-shop' for both peer-to-peer experience sharing and leading solution providers - the UDI and Traceability Forum!
As UDI implementation continues in the North American regions, the global medical device industry is beginning to focus upon imminent European regulatory changes and the upcoming implementation for these geographies.
Regulatory bodies, device manufacturers, healthcare providers and numerous other stakeholders are gearing up for implementation in region which presents it's own specific challenges and opportunities.
Adherence to European specific regulatory specifications, both in labelling and packaging as well as data is a must, but in an increasingly competitive market, achieving compliance whilst maintaining a competitive edge and assuring ROI is of paramount importance also.
And what about direct part marking, what's happening there?
What if you get audited by the FDA? There has already been at least one FDA 483 warning letter citing UDI non-compliance; what can you do to make sure you're protected?
Join us at the Medical UDI & Traceability Forum to ensure that your company is maximising it's efforts for improving compliance, whilst maintaining your competitive edge!
Through regulatory discussions, panels, roundtables and practical case studies, this forum is tailored and uniquely positioned to highlight the state of urgency in the industry, address implementation challenges - plus maximise the ROI of your UDI implementation in the future, ensuring it continues to drive business value.
2017 Speakers Include:
Senior Regulatory Affairs Associate, EDMA UDI Task Force
Head of Biosciences and Implants, Devices Division
GUDID Program Manager
Senior Program Manager
Abbott Laboratories Inc
Head of Medical Supply Controlling
University Hospital Schleswig-Holstein
Who Is This Event For?
UDI Project Managers
Regulatory Affairs Directors & Managers
Labelling Directors & Managers
Packaging Directors & Managers
Supply Chain Directors
Healthcare providers & hospitals
Non-profit healthcare organisations
"Good variety of speakers from various organisations and extremely valuable to learn from the experiences of others"
"Very valuable insight into the struggles manufacturers are having."
"The mix of speakers from the industry on one hand and from authorities on the other is great"