For the sake of patient safety, the ability to track and trace medical devices at a global level is paramount. However there are some key considerations to be aware of when implementing UDI.
Download our useful guide to discover the benefits of UDI, discover how it is tracked, who it is relevant to and more: http://www.prisymid.com/resources/blog/399-the-useful-guide-to-unique-device-identification.
Warren is responsible for leading and driving results from the global sales team. He has a detailed knowledge of the auto-ID industry with particular emphasis on label lifecycle management and production techniques.
Warren is passionate in identifying and securing new business opportunities, whilst building business within our existing global client base to create year on year revenue growth.
We know from talking with clients and prospects alike that many are facing increasing challenges with FDA/EU regulatory compliance in their labeling operations. Combined with the continued drive for improving supply chain efficiency, this means current labeling systems are often not sufficient. Implementing a new labeling system can often seem a complex task so we wanted to highlight ways to reduce the impact of this, and ensure it’s done in the most efficient way.
Hopefully we’ll be able to show the audience how they can reduce the perceived validation pain of implementing a labeling lifecycle management solution, ensuring they are compliant with all relevant regulations, but also making the labeling process more efficient – reduce risk, reduce process costs and improve compliance!
There have been many! I think one of the best would be helping a medical device client realize savings of around $8M through supporting their move to print-on-demand. This meant they could dramatically reduce the amount of paper wastage by printing country specific IFU’s. It saved them around 175 tonnes of paper wastage, which has to be good for the environment too!
Sri Lanka…. Great people, good culture and cricket!!
Increasing operational efficiency is an aim for all medical device manufacturers and is a driver for change for many organizations. But the question is how without affecting every day operations?
Many proactive medical device companies are already beginning to take a more strategic approach to the management of data and are implementing single, fully integrated, end-to-end label lifecycle management systems that capture, store and disseminate data safely, quickly and accurately for increased label integrity. The deployment of such validated systems can improve efficiency by reducing the number of unnecessary manual checks, improve quality control throughout the lifecycle and accelerate product to market.
Moreover, the use of centralized data creates a robust platform for a ‘single version of the truth’ that can be used to generate and print labels ‘just in time’ – ensuring that the right information goes on the right product at the right time, every time. The obvious implications of product recalls are significant and costly; efficiency and productivity take a major hit, whilst the potential damage to brand reputation and patient safety are equally severe.
Through the implementation of a more flexible, transparent and accessible system for version control, medical device organizations can save money as well as increase operational efficiency by managing product labels centrally – irrespective of country , language or regulatory requirements. By implanting secure, web based solutions they can also allow and manage correct access levels to third party manufacturing, packaging and labeling operations, again aiding efficiency objectives.
The industry can undoubtedly benefit from implementing standardized mechanisms to control data globally and, as a consequence, mitigate the expensive risk of mislabeling. If companies are able to manage and structure data correctly, then all the downstream benefits will emerge for free; label creation, workflow processes, inspection capabilities and audit control all flow from ensuring the right data is available to the right people at the right time. And, the efficiency gains are a natural and welcome byproduct.
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