01
U.S. & global regulatory strategy
Plan for U.S. entry now and global expansion later. Build testing and evidence plans with future markets in mind.
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.
U.S. and global strategy. Submission support. Post-market guidance. We meet you where you are.
02
Q-Subs & FDA interaction
Prepare focused FDA questions. Build the right materials. Leave with clear next steps.
03
510(k) submissions
Turn your strategy and evidence into a clear, cohesive submission.
04
De Novo & Breakthrough support
Develop the De Novo submission. Assess Breakthrough eligibility. Prepare the request and rationale.
05
eSTAR & submission publishing
Prepare the eSTAR. Organize attachments. Complete final checks for FDA electronic submission.
06
Post-market support
Plan expanded indications, next-generation devices, 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 today’s priorities and keep future indications, versions, and markets in view.
Start with the right questions.
We learn your device, intended use, development stage, and target markets. Then 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.
Work directly with the person doing the work. Set a clear scope. Focus on what matters. Keep regulatory work tied to business goals.
A direct partnership.
One close working relationship. Clear communication. Direct access to your regulatory partner.
Right-sized to your needs.
Clear scope. Thoughtful priorities. Practical support for startup budgets.
Strategy through execution.
Support from early strategy through submissions, post-market changes, and market expansion.
Templates & toolkits
Practical tools for regulatory work.
Editable resources for evidence planning, Pre-Sub preparation, and predicate comparison.
Resources
Ideas for your
next step.
Seminars, practical tips, and regulatory 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 short session for founders on testing, evidence, and FDA expectations.
October 8, 2026 · 12:00–12:45 PM Pacific
Engaging FDA Strategically
A practical conversation about when to approach FDA, how to prepare, and what to do next.
Turning FDA feedback into a focused strategy
Use a traffic-light approach to sort alignment, clarification, and strategic risk.
04 / Meet the founder
A direct line to the person
doing the work.
Mirna Hassoun
Founder and Principal Consultant
Mirna holds a master's degree in Biomedical and Translational Science. She began in clinical research and later moved into regulatory affairs.
Her experience covers Class II and Class III devices, combination products, IVDs, SaMD, software-enabled devices, and AI.
Through Strata, she works directly with founders on U.S. and global strategy, submissions, 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. Tell us where you want to go.