Head of Quality Assurance & Senior Development Engineer, Technolution
Discover the strategies and best practices for onboarding off-the-shelf device platforms into your organization. This workshop will explore the critical considerations, potential challenges, and innovative solutions that ensure a smooth integration process, enhancing your product's market readiness and patient-centricity.
Learn how to align your Quality Management System, implement essential tools, and provide comprehensive training for your personnel to guarantee compliance and efficiency throughout the integration process.
Nancy brings over 25 years of hands-on experience in Medical Devices and Pharmaceutical Packaging, with a strong focus on integrating off-the-shelf solutions into combination products. She specializes in aligning Quality Management Systems to business objectives, ensuring compliance, efficiency, and patient-centric outcomes. With a background as an ISO Lead Auditor and expertise spanning Quality Management, R&D, Production, and Supply Chain, Nancy excels at developing streamlined, business-oriented quality processes. She holds a Master's in Mechanical Engineering from Aalborg University and additional business education from London Business School.
Martin is an experienced engineer with over a decade of expertise in medical device development. Holding a Master of Science in Engineering from Aalborg University, he specializes in transforming ideas into market-ready products, managing the process from concept to verification. With six years as a line manager at LEO Pharma and certification in the Scaled Agile Framework (SAFe), Martin combines leadership, agile methodologies, and product management to drive innovation. He is particularly passionate about setting new standards for autoinjectors, with a strong focus on sustainability and innovative approaches to product development.