Postgraduate Certificate in Medical Device Validation
Published on June 28, 2025
About this Podcast
HOST: Welcome to our podcast, today we are joined by an expert in the field of medical device validation. Can you tell us a bit about your experience and what led you to teach this Postgraduate Certificate course? GUEST: I've spent over 20 years working in regulatory affairs, quality engineering, and medical device design. I've seen firsthand the importance of proper validation in ensuring safety and compliance. I'm passionate about sharing my knowledge to help others excel in this critical area. HOST: That's fantastic. This course is designed for regulatory affairs professionals, quality engineers, and medical device designers. In your experience, what are some common challenges these professionals face when it comes to medical device validation? GUEST: There are several challenges, including understanding and navigating critical standards like ISO 13485, mastering validation methodologies for software, hardware, and processes, and keeping up with changing regulations and industry trends. HOST: Speaking of industry trends, can you share any current trends that are particularly relevant to this course or medical device validation in general? GUEST: Absolutely. Digital health and smart devices are gaining popularity, which brings new validation challenges. Additionally, remote auditing and regulatory inspections are becoming more common due to the pandemic, requiring professionals to adapt and enhance their virtual skills. HOST: That's fascinating. How does this course help students overcome these challenges and stay ahead in the industry? GUEST: The course focuses on risk management, design control, and regulatory compliance, providing students with the essential skills and knowledge needed for successful medical device validation. It also offers practical experience through case studies and real-world applications, enabling students to tackle challenges with confidence. HOST: It sounds like a comprehensive and valuable course. As we wrap up, what are your thoughts on the future of medical device validation and how this course might help shape it? GUEST: I believe medical device validation will continue to grow in importance as technology advances and regulations evolve. This course equips professionals with the tools they need to drive innovation, ensure safety, and maintain compliance in the ever-changing landscape of medical device development. HOST: Thank you so much for joining us today and sharing your insights on the Postgraduate Certificate in Medical Device Validation. It's been a pleasure having you on the show. GUEST: Thank you for having me. It's been a pleasure discussing this important topic with you and your audience.
