Global Medical Device Podcast powered by Greenlight Guru

#352: Fundamentals of Quality & Regulatory

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Jan 18, 2024

In this podcast, they discuss the importance of project management skills in quality and regulatory work in the medical device industry. They also cover topics such as influencing business leaders with quality, understanding changing regulations, designing products with the end user in mind, and the concept of design freeze in the medical device industry.

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Introduction

00:00 • 3min

Getting Involved in Quality Assurance in Medical Devices

02:56 • 4min

Perception of Quality and Importance of Education and Partnership

06:52 • 2min

Optimizing Processes and Prioritizing Design Controls for Success

08:55 • 2min

Influencing Business Leaders with Quality

10:31 • 3min

Understanding Changing Regulations in the Medical Device Industry

13:12 • 19min

Personality Testing and Designing Products with the End User in Mind

32:17 • 3min

The Concept of Design Freeze in the Medical Device Industry

35:40 • 15min

In this episode, we delve into the complexities and essentials of quality and regulatory roles in the medical device industry. Our esteemed guest, Jennifer Mascioli-Tudor, CEO and founder of JMT Compliance Consulting, shares her wealth of experience from top MedTech companies, underscoring the importance of proactive quality management, project management skills, and the ability to influence and communicate within organizations.

Key Timestamps:

[00:00:50] Introduction to Jennifer Mascioli-Tudor and her extensive background in the MedTech industry.
[00:03:30] Jennifer's origin story in quality and regulatory roles.
[00:07:15] The pivotal learning moments in quality management and regulatory affairs.
[00:10:45] Strategies for influencing business leaders and the importance of storytelling in quality and regulatory roles.
[00:16:30] The significance of human factors in product design and learning from end-user feedback.
[00:21:50] Project management skills for quality and regulatory professionals.
[00:25:20] The concept of 'design freeze' in the MedTech space and its impact on product development.
[00:29:55] Jennifer's insights on agility and adaptability in building a quality management system.

Quotes:

"A really good quality and regulatory professional needs to have really good project management skills." - Jennifer Mascioli-Tudor
"It's not just about the design and about the product. It's about everything ancillary that feeds into that finished medical device." - Jennifer Mascioli-Tudor

MedTech Trends:

An emphasis on proactive quality management to ensure patient safety and product efficacy.
The rising importance of human factors and user-centered design in medical device development.
The shift towards integrating software and digital solutions in medical devices.

Practical Tips:

Quality and regulatory professionals should hone their project management skills.
Communication and storytelling are key in influencing business decisions and leadership.
Always present solutions and alternatives when addressing compliance challenges.

References:

Questions for the Audience:

Discussion: "How do you envision MedTech changing the landscape of healthcare in the next decade?"

Feedback:

Love the episode? Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru and leave a review on iTunes!

Sponsors:

This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Streamline your process and foster innovation with Greenlight Guru’s intuitive platform!