S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements

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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

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