RQM+ Live! is an interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists also answer your questions live! Every episode is added to our podcast, too.
Medical device and IVD labeling has always been a challenge for manufacturers because updates are often required when new regulations are introduced. With the piecemeal approach that is commonly taken, the result is a product box covered in labels or inconsistent language and placement across product lines. This can be confusing and overwhelming for end users.
With the implementation of MDR and IVDR requiring significant labeling revisions, manufacturers should consider it an opportunity to start with a blank slate to both achieve global market compliance and eliminate duplicate and inconsistent information.
The reality is that labels will always need to be updated, and manufacturers need processes and systems for:
Led by global regulatory experts with more than 25 years of experience, this show will discuss how to start over with labeling and create a streamlined process for future updates. By making an investment now, manufacturers will see long-term benefits, such as minimizing the impact of future updates and better streamlining for managing large-scale changes.
- Updating labels based on regulatory and customer requirements
- Keeping track of label changes for all products
- Assessing global impact to label changes
- Determining when to do a comprehensive label assessment
- Implementing label changes that follow best practices
- Creating new labels after an acquisition or merger
- How to respond when an error is found
Please join us to be inspired and informed and bring your tough how-to and what-if questions for our panel discussion.
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
- Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services
- Kevin Go – Project Engineer, RAC (former FDA CDRH Lead Reviewer)
- Laurie Petit, PMP – Principal Advisor