Medical Device: How to Identify, Address and Remove the Risks of Labeling Product Recalls
Date: Thursday, 2019 January 24, 11:00 AM New York/4:00 PM London, 1- hour duration
Join medical device labeling and data experts from PRISYM ID and Reed Tech to find out the latest recalls trends from the industry, to hear about industry real-life scenarios and see how the right software platforms can help you deliver an effective strategy to minimize the risks of labeling recalls.
Every year, the FDA and MHRA recall medical devices due to labeling issues. To give you a better idea, labeling is no 4 in Top 10 Recall Root Causes in 2018, with Packaging being no 8, Software design being no 5 and Employee error being no 6.
Why is labeling such an important root cause in medical device recalls? It may be because many medical device manufacturers are still trying to resolve the issues in isolation, and not identifying the risks before product launches and not putting in place systems and procedures to avoid product recalls to happen.
Being pro-active proved beneficial for the organizations who looked at the cause and invested in market risk assessment platforms to identify and manage product risks or in validated labeling platforms which can offer complete label integrity to meet the strictest compliance requirements for FDA & EU regulations.
Key Learning Objectives:
- Develop an understanding of the common causes of labeling recalls and how they can be avoided
- Find out what are the medical device trends for product recalls
- Understand how manufacturers can meet the increasing compliance demands from both the FDA and European regulators
- Watch 15 min demo of practical examples of how Reed Tech’s Navigator™ for Medical Device Risk Assessment can help you
- Watch 15 min demo of practical examples of how PRISYM ID’s Label Management Software can help you
MEET OUR SPEAKERS
Steve Ellison, VP of European Sales, PRISYM ID
Steve has spent over 24 years working with coding and labelling solutions and for the last four years he has been running the European Sales Consultancy team, promoting and implementing PRISYM ID’s world class labelling software solutions.
During his time with PRISYM ID, he has observed many changes within the industry including significant tightening of regulations, the challenges of globalization, implementation of directives such as UDI and EU MDR.
Rachel Benway, Product Manager, Reed Tech
Rachel is a Product Manager in the Reed Tech Life Sciences group. Rachel believes that the development and integration of intuitive software will lead to more affordable and effective healthcare. She has been working in the field of healthcare technology for the past 7 years. Rachel holds a bachelor’s degree in Biomedical Engineering from Drexel University and a Master’s degree in Health Informatics from Temple University.
Craig Jones, VP Enterprise Sales Engineering, PRISYM ID
Craig Jones has the responsibility for understanding customer needs and industry challenges to drive solutions to improve efficiency, minimize risk, address regulatory requirements and provide new approaches to business systems and processes.
Craig has 15 years of experience delivering validated label lifecycle management solutions to life science and healthcare industries including medical device, pharmaceutical and clinical trial organizations. His experience includes roles as an industry consultant, in IT management and as a senior manager for global technical support and professional services.