Free Resources
I believe access to tools and templates that provide fundamental knowledge and guidance to successfully navigate regulated product development should be FREE. I hope to grow this library over time and am always open to suggestions and requests!
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!
Design and Development Records - What you actually submit to a regulator
This DDF Submission Map breaks down the records generated across the medical device design lifecycle and clearly shows which documents are submitted to FDA and EU Notified Bodies versus which must simply be audit-ready. Grounded in ISO 13485 and FDA’s Quality System Regulation, this visual map helps teams understand how design controls translate into real, reviewable documentation—from planning and risk management through verification, validation, and design transfer.
Whether you’re new to medical devices or tightening up an existing development process, this resource helps you build a DDF that is traceable, defensible, and regulator-ready—without over-documenting.