Quality Grind Podcast
Welcome to The Quality Grind Podcast, presented by Medvacon! Join hosts Joe Toscano, President of Medvacon, and Mike Kent, Director of Learning Platforms, as they (we) have some fun while tackling topics related to the “everyday grind” within Life Science industries.
Featuring conversations with key industry players, they’ll dive into their unique problem-solving strategies, career paths and personal interests. Most importantly, their (our) goal is to cultivate a community where information and experiences can be shared with and for the benefit of all, emphasizing the diversity of approaches to industry challenges and the importance of continuous engagement and learning.
Quality Grind Podcast
Quality Grind Short - Medical Devices: Get Ready for QMSR and ISO 13485
Welcome back to The Grind! In this Short episode, we highlight the upcoming changes to 21 CFR 820, which governs medical devices in the U.S. Learn ways to assess your readiness to comply with the new Quality Management System Regulation (QMSR) and its alignment with the ISO 13485 standard.
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Welcome back to The Grind, everyone! Medical device manufacturers and developers, are you ready for new regulations to become effective? Curious about what's changing? Let's take a "Short" look.
The FDA is updating 21 CFR 820, the regs that govern medical devices in the United States. The new Quality Management System Regulation, or QMSR, will include some pretty significant changes that will have a direct impact on your organization.
The biggest of those is the adoption of ISO 13485, the international standard that details quality system requirements for medical devices.
The FDA will increase its focus on Risk Management, Supplier Management and how engaged executive [00:01:00] management is in quality oversight.
They will also now be able to review records to more rigorously evaluate the effectiveness of these and other oversight activities, including internal and external audit reports and Quality Management Review records.
This also means FDA could simply head directly for the clothes hamper in your closet because all of your dirty laundry is now available for them to look through. But before you head for the washing machine with a gallon of bleach, take some time to evaluate what state your quality records are in, how they got to their present condition, and most importantly, what can be done from a process perspective to ensure future records don't end up getting soiled.
By way of example, the closure of a quality record is seldom the accomplishment that we think it is. Did the record simply document [00:02:00] what happened and what we did to fix the isolated event? Or does the record prove we resolved and prevented the recurrence of the root cause? FDA has been asking us to focus on effectiveness for a long time. You can bet they'll be turning up the heat even more on companies that can't demonstrate tangible and sustainable results out of their Investigation and CAPA programs.
Now, let's talk about Quality Management Review. Firms should be prepared to demonstrate, again, with objective evidence, that these forums are more than an agenda and a signed attendance sheet. Expectations of executive management are going to increase with the new regulation in place. When and to what degree did senior leaders know about the issues? Is there proof that their active involvement, timely decision making, appropriate reallocation of resources, [00:03:00] and direct oversight all led to a quantifiable reduction in risk?
FDA seems to be signaling that the future will be even more about accountability than checked boxes. Will your firm be ready? Who in your organization is assessing your current systems, the risks associated with any gaps, and driving the implementation of effective action plans. Now, if everyone is pointing at the Quality Manager or Quality Director, there's your first challenge.
So where can you go to gain perspective, ask questions and solicit ideas? Start by reviewing the regulations and the ISO 13485 standard. Read warning letters, but from the perspective of, "Do we have the controls in place right now to effectively prevent this from happening here?" Engage industry experts and [00:04:00] trade organizations to discover what's worked elsewhere and to help you adapt it to your unique environment. Heck, you could even call the FDA district and ask for a consultation! It's not as crazy as it sounds. But more than anything else, start whatever you're going to do, now.
What are your thoughts? How is your team preparing to meet these new requirements? We invite you to engage us in discussion on LinkedIn or any of Medvacon's social media outlets. And be sure to check out the resources we have available on our website to help you navigate this change with confidence.
Thanks for watching, and we'll see you again next time here on The Grind.
If Medvacon can help you and your organization, we're happy to do so. We specialize in the following areas. Quality and Compliance, Validation and Qualification Services, Project Management, [00:05:00] Tech Transfers, General and Specialized Training Programs, Engineering Services, and Talent Acquisition. If you have general questions as well, feel free to give us a call at any time.
We can easily be reached at 833 633 8226 or via our website at www. medvacon. com. Thanks so much, and we look forward to speaking with you.
Thank you for listening to the Quality Grind Podcast presented by Medvacon. To learn more or to hear additional episodes, visit us at www. medvacon. com.