USDM Life Sciences’ Medical Device Experts to Present at LiveWorx 2018 in Boston
SANTA BARBARA, Calif. (PRWEB) June 18, 2018 -- USDM Life Sciences, the leading risk management, technological innovation and business process optimization firm for the life sciences and healthcare industries, announces that Jay Crowley, James Macdonell, and Marti Velezis will speak at PTC LiveWorx 2018 in Boston from June 17-20, 2018.
- What: Panel Discussion - “Closed-Loop Quality for Medical Device Innovators”
- When: Monday, June 18, 2:30-3:15pm
- Where: LiveWorx 2018, Boston Convention and Exhibitor Center, Boston, MA
- Who: James Macdonell, Vice President of Medical Device Services and Solutions at USDM Life Sciences
With patient outcomes and lives at stake, quality is paramount for medical device innovators. Yet surveys show that fewer than 40% of medical device companies are able to close the loop on quality by making timely and accurate quality information consistently available to key stakeholders. This panel discussion will explore best practices from leaders who are driving or supporting product quality initiatives for their companies. We’ll explore the relationships between quality and compliance, quality and innovation, and how to transform a quality philosophy into a repeatable process.
- What: “UDI Eats the World: Exploring Regulatory Issues for Life Sciences”
- When: Tuesday, June 19, 4:15-5pm
- Where: LiveWorx 2018, Boston Convention and Exhibitor Center, Boston, MA
- Who: Jay Crowley, Vice President of UDI Services and Solutions at USDM Life Sciences and Marti Velezis, UDI Technical Specialist at USDM Life Sciences
This session will address the various growing global UDI database issues medical device manufacturers are facing. It will give participants an opportunity to hear what medical device companies need to be concerned about – including the key considerations in building a programmatic strategy that can support the US UDI, EU MDR/IVDR, and other evolving global data needs. Known as the “father of UDI,” Jay Crowley developed the framework and authored key requirements for FDA’s Unique Device Identification System and led the team responsible for the development and implementation of UDI requirements. Marti Velezis led the development of FDA’s GUDID – and is a well-recognized global standard’s expert. This is your opportunity to learn about UDI from the source – and identify key strategies for a sustainable response.
“I look forward to discussing UDI and the EU MDR at LiveWorx,” said Crowley, VP of UDI Services and Solutions at USDM. “I’ll explain how to develop a program that will support your UDI efforts at home and abroad. As UDI-like regulations continue to develop around the world, now is the time to get prepared and get ahead.”
Jay Crowley is the Vice President of the Unique Device Identification Services and Solutions at USDM Life Sciences. Jay was most recently Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for FDA’s Unique Device Identification system. At USDM Life Sciences, Jay focuses exclusively on providing business process, technology and compliance solutions for the regulated life science industry. Jay held a variety of positions over his nearly 27 years at FDA, including work with design control regulations to reduce the chance of human errors with medical devices, patient safety and adverse event reporting. Jay also worked in the Office of the Commissioner of FDA, and the Office of Compliance at FDA.
Jim Macdonell is the Vice President of Medical Device Services and Solutions at USDM Life Sciences. He is an experienced consulting manager with over 20 years of defining client program needs and building and managing implementation teams. His experience includes compliance programs, MES systems, laboratory systems and ERP programs. Jim has developed life sciences solutions, managed client engagements, built delivery teams and managed distribution projects. Jim developed many of the IT and Compliance programs at USDM, including our Unique Device Identification (UDI) and Drug Supply Chain Security Act (DSCSA) compliance services and solutions for the medical device and pharmaceutical industries.
Marti Velezis is a UDI Technical Specialist at USDM Life Sciences. Marti has been instrumental in the process analysis and technical design, development, and support for medical device companies, application vendors and medical device regulatory agencies for UDI and other medical product submission and process systems.
USDM’s Medical Device division helps customers bring the right products to market faster, monitor their products in the field, handle post-market surveillance while addressing a variety of regulatory challenges unique to Medical Device industry.
USDM helps customers:
- Accelerate Quality System and Compliance effectiveness
- Accelerate PLM / QMS Integration and Closed Loop Quality
- Accelerate supply chain with master data management and deployment of enterprise systems
- Accelerate adoption of Cloud Solutions by implementing intelligent, compliant, digital transformation: reducing paper processes and data center footprint
- Accelerate Service Delivery by Managed Services Solutions
LiveWorx 2018 is a global technology conference and marketplace for solutions engineered for a smart, connected world. LiveWorx 2018 is at the Boston Convention and Exhibitor Center in Boston, MA, from June 17-20, 2018.
USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative companies in the world and boasts a staff of industry leading experts in the areas of technology and compliance. USDM Life Sciences is doing business as USDM Europe GmbH in Germany.
Ryan Carmel, USDM Life Sciences, +1 805-856-2660, [email protected]
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