Introducing the Project
Over the past few years working in med device, I’ve noticed something consistent across teams, the regulations themselves are rarely the real barrier. The challenge is translating those expectations into clear, repeatable ways of working that fit the realities of modern product development.
Most teams know what they need to comply with.
Far fewer have a shared understanding of how to operationalize it.
To explore this gap more deeply, I’ve started building this small, research driven website focused on processes and best practices for digital health compliance. It’s is a space to think out loud, to synthesize the literature, map the operational challenges, and articulate practical frameworks that help teams work better together.
The site will begin with a survey that pulls together regulatory guidance, industry papers, and emerging patterns in SaMD and digital health. From there, I’ll be building out a structured set of resources, including:
- Best practice guides for DHF structure, agile to regulatory mapping, risk first planning, and audit readiness
- Process frameworks that make compliance more predictable and less reactive
- Case patterns that illustrate how different types of teams can apply these approaches
- A resource library of checklists, diagrams, and explainers to support day to day execution
My goal is simple, create a clear, evidence based body of knowledge that helps digital health teams operationalize compliance without slowing innovation.
This is a learning project for me, and a way to contribute something useful to the broader digital health community. I’ll be sharing pieces of it as I go.
More soon.