Free Resources
I believe companies should have access to free tools and templates that provide fundamental knowledge and guidance to successfully navigate regulated product development. Use these resources however you'd like! No paywall, no contact info required.
How to Create a SaMD Regulatory Strategy
In this "How To" guide series, I have listed a series of questions I would typically ask a client when creating a regulatory strategy along with notes throughout to help guide you in the right direction. Each "How To" guide breaks down the 5 key elements to a SaMD regulatory strategy.
Creating Predictable SaMD Development and Launch Timelines
If your product development and launch timeline is not comprehensive, you'll start behind. It's important to plan thoroughly. Read this resource full of milestones to track, insights, and common mistakes so you can avoid day-one set backs!