How to Build with Confidence in MedTech

 The 5 Stages of Global Design and Development Guide and Checklist

How to Follow FDA guidelines in Medical Device Manufacturing

Executive Summary

Innovative medical devices have a lengthy design and approval process resulting in a large, but necessary initial investment. Device recalls can be devastating for users and manufacturers alike. When an error occurs in medical technology the failure impacts not only the company at fault but the lives of those who rely on the medical device. 

Risk reduction should therefore be at the forefront of any Medtech designer’s mind. The standard Global Design and Development model is a proven way to limit risk and maintain quality while designing the next generation of medical technologies. Based on the FDA Quality System Regulations and ISO 13485, the model consists of five essential steps: user needs, design input, design process, design output, and finally the medical device. We describe each stage of this process and provide insights on how to leverage each step to accelerate your Medtech product. The timing of design review, changes, verification, and validation are mapped out within the model, ensuring that you and your team are validating your design at every step of the design design and fabrication process.

Also included in the document is an essential checklist that details the 23 must-haves for a Product Requirement Document.

Ensure that you have a solid foundation upon which to develop innovative medical technology and reduce risk at the earliest stage.

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