| Design and Development is one of the most challenging and most heavily scrutinized areas by regulators. The FDA’s Quality Management System Regulation (QMSR) and ISO 13485/ISO 9001 both place detailed requirements on how organizations plan, document, and control their design processes. Missing even small details in inputs, reviews, or verification activities can lead to audit findings, FDA warning letters, or costly rework.
This on-demand webinar will give you a clear and practical overview of what Design and Development compliance looks like and highlight the most common pitfalls. You will leave with actionable insights you can apply right away to strengthen your quality system and prepare for audits or inspections. In this recording, you’ll learn:
This webinar will be especially useful for:
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Markus Gee has 30+ years of industry experience in Quality System implementation & management with the ISO 9001 and ISO 13485 standards. This includes product development, validations of processes and products, etc. Markus’s auditing experiences help relay what you can do to react to prepare for audits and inspections and ensure that your design and development requirements are met.
Axeon’s Design Control Training for Design & Development Requirements course gives you the skills and knowledge to implement, manage, and audit design and development activities with confidence. Whether you are new to design controls or seeking a structured refresher, this course will help you interpret the requirements and apply them in real-world scenarios.
Delivered in a live, instructor-led format, this course offers an engaging and flexible way to strengthen your design and development expertise without stepping away from your day-to-day responsibilities.
November 21, 2025 | 12:00 PM MT | 2:00 PM ET
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