S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements

Being an Engineer

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Steve Gompertz discusses the complexities of navigating the regulatory landscape in the medical device industry. He shares insights on the evolution of global regulations, the balance between innovation and quality control, and strategies for developing effective quality management systems for companies of all sizes.

Main Topics:

• Regulatory compliance in medical devices
• Tailoring quality management approaches for small vs. large companies
• The core components of a quality system and its evolution over time
• Emerging trends in medical device regulations, such as AI and cybersecurity
• Improving quality management systems and achieving regulatory compliance

Steve Gompertz is a highly experienced leader in quality systems management and regulatory compliance, currently serving as a partner at QRx Partners. With a career spanning over 30 years, he has held significant roles in various companies, including Pelican Biothermal, St. Jude Medical, Boston Scientific, and Medtronic. At QRx Partners, Steve specializes in quality systems development, project management, and engineering automation, helping companies navigate complex regulatory environments and enhance their quality management systems​

Links:
Steve Gompertz - LinkedIn
QRx Partners Website

About Being An Engineer

The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with relevant companies, technologies, people resources, and opportunities. We feature successful mechanical engineers and interview engineers who are passionate about their work and who made a great impact on the engineering community.

The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us

Chapter

1. Simulation in product development with industry expert. (00:00:00)

2. Career choices and paths taken in engineering and technology. (00:02:31)

3. Regulatory compliance in medical devices, with a focus on balance between innovation and quality control. (00:05:49)

4. Regulatory compliance and quality management for medical devices, with focus on tailoring approaches for small vs large companies. (00:12:15)

5. Quality system development for medical devices, focusing on evolution and key components. (00:15:27)

6. Quality management systems for medical devices. (00:21:42)

7. Medical device regulations, AI, and cybersecurity in the medical field. (00:24:30)

8. AI in surgery, potential benefits and concerns. (00:31:10)

9. Improving quality management systems and regulatory compliance. (00:33:48)

10. Quality management in medical devices, importance of systems thinking and problem-solving skills. (00:40:11)

11. Efficient project management techniques in engineering. (00:43:47)