01
U.S. & global regulatory strategy
U.S. entry now, global expansion when you’re ready. Evidence and testing plans that consider today’s requirements and tomorrow’s target markets.
Clarity. Strategy. Execution.
U.S. and global regulatory strategy. From concept onward.
For medical device founders who need more than a roadmap. Strategic direction and hands-on support for U.S. market entry, global planning, submissions, and post-market needs. Move forward today while keeping future international expansion in view.
- Founder-focused
- Direct partnership
- Purposeful execution
Built for your next milestone
Medical device foundersEarly-stage teamsGrowing medtech companies
01 / Our expertise
The right expertise.
At the right moment.
From U.S. entry and global strategy to submissions and post-market support, we meet you where you are.
02
Q-Subs & FDA interaction
Focused preparation for meaningful FDA dialogue, from the questions you ask to what comes next.
03
510(k) submissions
Hands-on support to turn your strategy and supporting evidence into a cohesive submission.
04
De Novo & Breakthrough support
De Novo submission development and Breakthrough Device designation support, including eligibility assessment, supporting rationale, and request preparation.
05
eSTAR & submission publishing
Hands-on eSTAR preparation, attachment organization, and final checks to meet applicable FDA electronic submission requirements.
06
Post-market support
Support after market entry, from expanded indications and next-generation devices to regulatory change assessments, ongoing obligations, and new markets.
A focused project. A defined milestone. Or ongoing support. We shape the engagement around your needs.
Find your starting point02 / Our approach
A clear direction.
A deliberate next step.
Every device and market is different. We focus on your immediate priorities while considering future indications, product versions, and international expansion.
Start with the right questions.
We get to know your device, intended use, development stage, and target markets. Whether the U.S. is your only immediate priority or part of a broader plan, we identify the decisions that matter now.
What this gives youA shared view of priorities and gaps
03 / The Strata difference
Experienced guidance.
Without unnecessary
layers.
You work directly with the person doing the work. We define the scope, prioritize what matters, and keep your regulatory effort connected to your business goals.
A direct partnership.
One close working relationship. Clear communication. An engaged regulatory partner who understands your program.
Right-sized to your needs.
Clearly scoped engagements and thoughtful priorities, with respect for the realities of startup resources.
Strategy through execution.
Practical support from early strategy and submissions through post-market changes and future market expansion.
Resources
Ideas for your
next step.
Seminars, practical tips, and thoughtful perspectives for medical device founders.
Explore all resources
Upcoming live session
How Much Evidence Will FDA Expect?
Register for the seminar
This session has ended.
October 8, 2026
12:00–12:45 PM Pacific
How Much Evidence Will FDA Expect?
A free virtual session for founders and early-stage teams, with a practical presentation and live Q&A.
October 8, 2026 · 12:00–12:45 PM Pacific
Engaging FDA Strategically
A candid conversation with Bruce Prothro about when to approach FDA, how to prepare, and what to do with the feedback.
Turning FDA feedback into a focused strategy
A traffic-light approach to Pre-Sub preparation: where FDA is aligned, where clarification is needed, and what may change the strategy.
04 / Meet the founder
A direct line to the person
doing the work.
Mirna Hassoun
Founder and Principal Consultant
With a master's degree in biomedical and translational science, Mirna began her career in clinical research roles before transitioning into regulatory affairs.
Her experience spans numerous therapeutic areas and includes Class II and Class III medical devices, combination products, in vitro diagnostic devices (IVDs), software as a medical device (SaMD), and devices incorporating software and artificial intelligence (AI).
Through Strata, she partners directly with founders and growing teams on U.S. and global regulatory strategy, submission execution, and post-market support.
Start a conversation with MirnaLet’s move your next milestone forward
Your next step deserves
a clear plan.
Tell us where you are — and where you want to go.