When should you create a URRA and perform formative testing?

Frequently we see companies performing usability testing and creating risk management documentation as an afterthought in the design of a medical device. However, you should be creating a usability plan and a risk management plan in parallel with your overall design and development plan. Unfortunately, ISO 13485 doesn't say when to perform these activities. ISO 14971 and IEC 62366 also don't say when to perform these activities in relation to the overall design process.
In our live-streaming webinar scheduled for Friday, September 20, 2024, we will explain when these activities should be performed relative to other activities in your design and development plan. We will also share our combined template for a design and development plan. This template includes design controls, risk management activities, software development, and usability activities.
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