Webinar – Stop the Guesswork: Getting Design and Development Right

Stop the Guesswork: Getting Design and Development Right

 

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:

  • The critical FDA and ISO requirements that drive Design and Development compliance.
  • The most common mistakes manufacturers make and how to avoid them.
  • Practical steps to improve your documentation for audit and inspection readiness.

This webinar will be especially useful for:

  • Quality Managers and Engineers who want to better manage and audit Design and Development activities
  • Design and Process Engineers who want to integrate compliance into daily design work
  • Regulatory and Compliance Leaders who need to understand FDA and ISO expectations
  • Procurement Managers who want to see how supplier inputs affect design compliance
  • Anyone responsible for product realization and regulatory readiness
Design and Development: Two people looking down at a design on a table

 

About the Host

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.

 


To Learn More

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.