Life Sciences Blog

Step 1 in UDI Compliance: Assembling the Right Team

Apr 9, 2015 | Life Sciences, Unique Device Identification

After working with a number of medical device companies to successfully submit device records to the FDA, one important piece of advice from the experts at Reed Tech is to start by gathering the right team members from the beginning.

Initially, many in the medical device industry may have thought of UDI compliance as the responsibility only of the regulatory or labeling department. In reality, the FDA’s mandate has changed the way device companies must operate across many diverse business units.

Because of these changes, one of the most important things you should do before choosing an issuing agency or investigating submission solutions is to bring together the right resources internally. The stakeholders most affected include:

  • Compliance/Regulatory
  •  IT
  •  Labeling
  •  Legal
  •  Supply Chain

In small companies, the leaders of these divisions might all work under the same roof. But in many large companies, they may be spread out across not just different buildings but across different states or even countries.

The past experience of device labelers demonstrated how crucial it is to obtain executive buy-in to support UDI compliance from the start. Getting a senior executive to the table so they can truly understand and take to heart the necessary scope of a compliance program is vital to its long-term success.

Class I device labelers should start now and involve senior decision makers at the outset. Bringing together cross-functional teams to discuss what changes will be required in the supply chain side, what new processes the labeling department might need, and what data systems are needed from IT will enable the group to make the appropriate decisions in a timely manner.

Compliance with the FDA’s UDI requirements will necessitate changes in standard operating procedures and impact many different departments. Securing the participation of senior decision-makers in those departments from the outset will enable the UDI compliance program to proceed more smoothly. But it may very well bring an additional benefit—leaders who understand the reasons behind necessary changes to business operations will be better equipped to communicate to front-line employees not just how but why their jobs and processes might change as a consequence of the new regulations.

About LexisNexis Legal & Professional

LexisNexis Legal & Professional® provides legal, regulatory, and business information and analytics that help customers increase their productivity, improve decision-making, achieve better outcomes, and advance the rule of law around the world. As a digital pioneer, the company was the first to bring legal and business information online with its Lexis® and Nexis® services. LexisNexis Legal & Professional, which serves customers in more than 150 countries with 11,300 employees worldwide, is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers.

About LexisNexis Reed Tech

LexisNexis Reed Tech brings clarity to innovation for businesses worldwide. We enable innovators to accomplish more by helping them make informed decisions, be more productive, comply with regulations, and ultimately achieve a competitive advantage for their business. Our Reed Tech suite of SingleSource™ for Medical Devices, SingleSource™ for Drug Products, and Navigator™ for Drug Labels enables life sciences companies to create product data management strategies and meet compliance deadlines on time. We are proud to directly support and serve these innovators in their endeavors to better humankind.

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