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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.

Contact MEDVACON:

• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

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In today’s Short, Rhiannon Shadrick provides some strategies for candidates to increase their chances of landing that next job opportunity, identifying some tips for each phase of the interview process – Preparation, the Conversation and Following Up. Get your pen and paper ready – you’ll want to take some notes…

Contact MEDVACON:

• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

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In today’s Quality Grind Short, Mike Kent discusses some quick wins to make Training more effective and efficient for everyone involved. Improving effectiveness starts with reducing the amount of training, which provides a little more space to engage other people in the process and experiment with new ideas. These pointers aren’t just for Training professionals or those in QA – everyone benefits from actively participating in the training process.

How can you do that? Mike offers ways to discover creative options, anticipate challenges, and achieve better, data-driven outcomes.

Contact MEDVACON:

• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

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In this episode of the Quality Grind Podcast, host Mike Kent continues his discussion with Medvacon consultant Armin Beck about the newly amended 21 CFR 820, Quality Management System Regulation for medical devices. The duo explores the implications of new FDA inspection techniques, the importance of thorough gap analyses for readiness, and the increased responsibility of executive management in quality oversight. The lens widens to discuss the potential impact on not just medical device firms but also the broader Life Sciences industry. The episode also offers practical guidance and resources to help organizations align with the new requirements and avoid regulatory pitfalls.

Contact MEDVACON:

• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

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In this episode of the Quality Grind Podcast, presented by Medvacon, Mike Kent welcomes Armin Beck, a consultant in the medical device field, to discuss FDA's recent adoption of ISO 13485 as part of its amended Quality Management System Regulation. This change, effective February 2, 2026, reinforces the FDA’s focus on harmonizing US regulations with global standards. The conversation covers the implications for medical device companies, including the expansion of FDA access to audit reports and Quality Management Review records, as well as potential new agency inspection and oversight tactics. The episode also highlights the importance of Risk Management under ISO 13485 and how organizations can adapt to these new requirements. Tune in to learn the steps your company can take to navigate these changes effectively.

Contact MEDVACON:

• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

Thanks for listening! Don't forget to follow us @medvacon on all platforms for updates on blogs and podcasts!

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In this episode of the Quality Grind Podcast, host Mike Kent and Medvacon consultant Kim Lim round out their exploration of Technology Transfer, identifying the critical strategies that foster a smooth execution process. Discover the value of thorough preparation, the significance of quality agreements, and the role of process performance qualifications (PPQ). Emphasis is placed on maintaining transparent and frequent communication between sponsors and contract partners, as well as fostering strong interdepartmental relationships. Tips for managing documentation and data are also highlighted to prevent pitfalls and ensure the creation of high-quality products. Perfect for anyone looking for actionable tips and expert advice!

Contact MEDVACON:

• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

Thanks for listening! Don't forget to follow us @medvacon on all platforms for updates on blogs and podcasts!

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In this episode of The Quality Grind Podcast, hosted by Joe Toscano and Mike Kent from Medvacon, we continue our exploration of Leadership with special guest Lisa Bourquin. Continuing from the foundations laid in Episode 10 about initiative and ownership, they explore the significance of being open to feedback and a more effective 'feed forward' approach, which focuses on guiding improvement rather than criticizing past mistakes. Lisa shares practical tips and stories illustrating how coachability fosters team success and how influencing and managing up can enhance organizational effectiveness. The episode concludes with insights on developing leadership programs that incorporate these vital skills.

Contact MEDVACON:

• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

Thanks for listening! Don't forget to follow us @medvacon on all platforms for updates on blogs and podcasts!

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In this episode of The Quality Grind Podcast, host Mike Kent continues the Technology Transfer series with Kim Lim, as the two illuminate more strategies for achieving successful collaborations between sponsor and contract partner organizations. Key discussion points include assessing the true capabilities of potential contract partners, the importance of early-stage technical reviews, and why relying solely on a Quality audit can leave sponsors with a potential false sense of security. Learn how CDMOs can differentiate themselves and help accelerate the development process.

Contact MEDVACON:

• Message us at @MedvaconLifeSciences on LinkedIn
• Visit our website at www.medvacon.com/contact
• Email us at qualitygrind@medvacon.com

Thanks for listening! Don't forget to follow us @medvacon on all platforms for updates on blogs and podcasts!