Regulatory strategy for startups in Dx and mistakes to avoid – Heinz Steneberg
This week on Diagnosing Dx, we’re joined by Heinz Steneberg, President and CEO of MDSS, for a deep dive into the role of Regulatory Strategy in Diagnostics and MedTech startups.
From early-stage planning to FDA engagement, we cover the decisions that make or break go-to-market timelines - and how emerging models are shaping the regulatory future.
🔥 What You’ll Learn:
• How to use FDA pre-submissions to clarify your path to approval
• What it takes to secure Breakthrough Designation - and why it matters
• The most common regulatory missteps made by startups
• How AI and direct-to-consumer…
The skinny
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