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Step 1 in UDI Compliance: Assembling the Right Team

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Class II medical device labelers can learn a great deal from the experiences of companies who have already implemented their UDI compliance programs for Class III devices. After working with a number of Class III 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.



Read the article at go.reedtech.com/raps-article

The experience of Class III 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 II 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.