Helping early-stage device founders move confidently through FDA, TGA, and EU MDR pathways — without hiring too early.
Regulatory uncertainty costs time, capital, and credibility. Saunee gives you structure, clarity, and execution that investors and regulators trust.
Fractional Regulatory & Quality Leadership
Senior RA/QA guidance for Seed–Series B medical device teams
Regulatory Pathway Strategy
FDA 510(k), PMA, TGA, and EU MDR guidance grounded in real-world success
Investor-Ready QMS Builds
ISO 13485 / QMSR aligned systems that satisfy both auditors and investors
Medtech founders, technical leaders, and early cross-functional teams building regulated devices who need:
Small teams. Big questions. High stakes.
Saunee brings practical regulatory leadership — not just theory. With experience across implantable systems, diagnostics, and digital health, we help you:
Regulatory isn’t a checkbox — it’s a strategic advantage when done right.
The firm is led by a global regulatory and quality executive with over a decade of experience bringing complex medical devices to market.
They have led FDA, TGA, and EU MDR programs for implantable, diagnostic, and digital health technologies, working at the intersection of engineering, clinical, and commercial teams. Their work has supported venture-backed startups as well as publicly listed medtech companies.
Before founding Saunee, the team held senior regulatory roles at companies building Class III implantable systems and global diagnostics platforms — where execution quality, not just regulatory theory, determined success.
Saunee exists to give founders the same level of regulatory clarity that large medtech companies take for granted — without the overhead.
We partner with you early and purposefully, keeping teams moving without unnecessary overhead.
Our engagements typically follow a structured rhythm:
We embed with your team so decisions are informed, timely, and unambiguous.
Week 1–2: Alignment
Rapid review of your device, intended use, and regulatory context to clarify risk and opportunity.
Month 1: Regulatory Roadmap
You receive a written plan covering classification, pathway, milestones, and evidence requirements.
Months 2–3: Execution
We help you build the QMS, submission structure, and clinical/regulatory artifacts.
Ongoing: Advisory
Continued support for regulators, auditors, and investor diligence.
This structure delivers senior-level regulatory leadership without the cost or friction of a full-time hire.
Do you replace a full-time regulatory hire?
No. Saunee provides senior regulatory leadership early, before it makes sense to hire a full-time Head of RA/QA.
Can you work with our existing consultants or CROs?
Yes. We routinely coordinate with CROs, test labs, and specialist consultants to keep programs aligned and efficient.
Do you handle submissions directly?
We lead the strategy, structure, and preparation of submissions and work closely with your team or external partners to execute.
What geographies do you support?
We support FDA (US), TGA (Australia), and EU MDR pathways, and help teams choose the fastest credible route for their first market.
How are engagements structured?
Most teams work with us on a monthly advisory or project basis, keeping costs predictable and support scalable.