S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements
Podcast: Being an EngineerPublished On: Fri Jul 19 2024
Description: Send us Fan MailSteve 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 devicesTailoring quality management approaches for small vs. large companiesThe core components of a quality system and its evolution over timeEmerging trends in medical device regulations, such as AI and cybersecurityImproving quality management systems and achieving regulatory complianceSteve 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 systemsLinks:Steve Gompertz - LinkedInQRx Partners Website Subscribe to the show to get notified so you don't miss new episodes every Friday.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 like cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us at www.teampipeline.usWatch the show on YouTube: www.youtube.com/@TeamPipelineus
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