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Join USDM at the MedTech Summit 2018 in Brussels, June 12-13, 2018! Jay Crowley, VP of UDI Services and Solutions at USDM will speak on June 12, 2018 from 10:20-10:45am: The Big Picture: UDI and the Product Visibility and Control Imperative There are many new UDI and UDI-like requirements being introduced globally. All of these are intended to bring visibility, control, and connectivity to the many related regulatory and commercial device-related activities. These activities cover the total lifecycle of a device – including design, manufacturing, distribution, and postmarket surveillance – and will ultimately include long-term safety, effectiveness, and value. All of this requires manufacturers to have a level of control and visibility over their products and processes that probably do not exist today, and which may require new systems to support these activities.  USDM will exhibit at the event; please stop by our booth, #14, on June 12 or 13th.…
Join the MedTec Europe 2018 conference in Stuttgart, Germany, where Jay Crowley, VP of UDI Services and Solutions at USDM Life Sciences will speak during two sessions: Breakfast Meeting at MedTec Europe 2018 Wednesday, April 18 10:00-10:45 Why start now: A practical approach to kick-starting your MDR/ IVDR implementation   Regulatory Update Wednesday, April 18 16:00-16:30 Processes and steps for managing UDI for the FDA, the EU MDR/IVDR, and other regulators globally   Medtec Europe is the preeminent medical technology platform showcasing the key trends and insights across the entire supply chain of the medical technology industry. It also serves as a prime location for business opportunities and start-up companies looking to present their innovations to investors.  The event brings together companies in the medical device supply chain to share ideas, meet partners, and discover, experience and source products & services from all stages of production in order to create the next generation of…
Join us at the 2018 UDI Conference in Baltimore, MD April 24-25, 2018. Jay Crowley, VP of UDI Services and Solutions at USDM will present at the conference on Tuesday, April 24 from 9:50-10:35am on "Global UDI-Related Activity: Update on EU UDI System." The annual UDI Conference is the ONLY event dedicated to guidance and training for those impacted by the UDI Regulation! For more information on the conference, click here. A conference sponsor, USDM will host a happy hour on Tuesday, April 24 from 5-7pm at the Baltimore Renaissance Harborplace for more additional networking opportunities. Click below for more information and to RSVP for the reception!  
Tuesday, March 20th: Box GxP Luncheon with USDM + DocuSign: Regulated and unregulated content, now in the same cloud Join our upcoming luncheon to learn how to: Leverage Box for your GxP content — such as collaborating with CROs — and consolidate expensive GxP-specific systems Cut validation time in half and save up to 75% in validation costs with always-on testing Meet CFR Part 11 requirements by integrating Box with e-signature providers, such as DocuSign Learn more and register here
Jay Crowley, VP of UDI Services and Solutions at USDM Life Sciences will present at BOSCON 2018 in Boston on Monday, March 19, 2018. His presentation, The US and EU MDR/IVDR UDI Requirements - Similarities, Differences and Implementation Issues, will include: An exploration of the similarities and differences between the US and EU UDI requirements Important implementation issuesWhat to expect from other countries as UDI becomes a global practice Learn more about BOSCON 2018
USDM Life Sciences is a sponsor at GENERATE 2018 - The CARA Conference! GENERATE is Generis' first ever CARA Conference. Who: Manu Vohra, VP of Content Management, Holger Braemer, VP of USDM GmbH What: GENERATE 2018 When: March 14-15, 2018 Where: The Fitzpatrick Hotel, Co. Dublin, Ireland GENERATE is a two-day conference packed with discussions, demos, case studies, product news, informative technical sessions and partner exhibitors – all intended to help maximise your investment in CARA and related products and services.GENERATE is also intended to provide ample opportunity to share news, meet with peers and discuss experiences and best practices. Learn more here.
USDM Life Sciences is the Gold Sponsor of the IT Transformation and Cloud Content Management Summit in Berlin, 8-9 March.  Bryan Coddington, VP of Cloud Development at USDM, is the Chairman on Day 2 of the Summit, and will present on Day 1. Come see Bryan speak on Thursday, March 8 at 2:20pm: Be a GxP Digital Transformation Hero Digital Transformation for Life Sciences is an exciting initiative but what exactly does it mean? Is it moving to the cloud, being more collaborative, going mobile, or integrating processes? And how can you setup your organization for success? This session will share how Digital Transformation can be rapidly adopted by Life Sciences organizations with the proper approach to process optimization, compliance, and technology. Visit Bryan and rest of our team at our booth!
USDM’s VP and Practice Lead - UDI Services and Solutions, Jay Crowley, will be a featured speaker at the UDI workshop being held on January 31st.    The workshop will discuss all things UDI including international harmonization. Attendees will have an opportunity to ask direct questions regarding specific questions about how to properly submit new 510(k)s including software, discuss design issues with FDA reviewers, better understand how to mitigate risk, hear about new suggested parameters for pediatric patient exposure to radiography, discuss single use device versus reprocessing of multiple use devices, understand direct marketing for small devices and discover devices that make up multiple device kits. In addition, attendees will get to see demonstrations of new UDI readers and software/hardware for uploading and printing UDI labels. Learn more here


  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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