Saunee Medtech Partners Book a call
§01 Practice Brief
Saunee Medtech Partners FDA · TGA · EU MDR Founded 2024 · Global

Fractional regulatory leadership for medtech.

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.

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Pathways
FDA 510(k) · PMA
Systems
ISO 13485 · QMSR
Jurisdictions
US · AU · EU
Stage
Seed → Series B
§02 What we do

Three disciplines, one practice — built for the moment between first prototype and first submission.

01 · Advisory

Fractional Regulatory & Quality Leadership

Senior RA / QA guidance for Seed–Series B medical device teams — embedded in your rhythm, accountable to your milestones.

Fractional RA Head of Quality Board Prep
02 · Strategy

Regulatory Pathway Strategy

FDA 510(k), PMA, TGA, and EU MDR guidance grounded in real-world success — not framework theory.

510(k) PMA TGA EU MDR
03 · Systems

Investor-Ready QMS Builds

ISO 13485 / QMSR-aligned systems that satisfy auditors and investors — scalable from first-in-human to first commercial shipment.

ISO 13485 21 CFR 820 / QMSR Due Diligence
§03 Who we help

Medtech founders, technical leaders, and early cross-functional teams building regulated devices.

  • — 01Senior regulatory judgment without a full-time hire.
  • — 02Practical execution plans that survive contact with reality.
  • — 03Confidence ahead of submissions, audits, and due diligence.
Small teams. Big questions. High stakes.
§04 Why Saunee

Practical regulatory leadership — not just theory.

With experience across implantable systems, diagnostics, and digital health, we help you:

  • 01Choose the right regulatory pathway the first time.
  • 02Build compliant, audit-ready systems.
  • 03Navigate regulators confidently from submission through review.

Regulatory isn't a checkbox — it's a strategic advantage when done right.

§05 About the founder

A practice led by operators — not consultants.

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.

10+ yrs
Medtech regulatory
leadership
Class III
Implantable &
diagnostic systems
3 regions
FDA · TGA ·
EU MDR
VC & public
Startups through
listed companies
§06 How we work

Embedded, purposeful, and light on overhead.

We partner with you early and purposefully, keeping teams moving without unnecessary overhead. Our engagements typically follow a structured rhythm:

Step 01

Assess

Rapid evaluation of your device, clinical intent, and regulatory exposure.

Step 02

Design

A clear, defensible regulatory roadmap tailored to your product and markets.

Step 03

Build

We help construct the QMS, evidence, and artifacts that regulators expect.

Step 04

Support

Ongoing advisory through submissions, audits, and investor diligence.

We embed with your team so decisions are informed, timely, and unambiguous.

§08 FAQ

Commonly asked.

Q.01 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.
Q.02 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.
Q.03 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.
Q.04 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.
Q.05 How are engagements structured?
Most teams work with us on a monthly advisory or project basis, keeping costs predictable and support scalable.

Let's get your program submission-ready.

Saunee Medtech Partners
Global practice
Engagements: monthly or project
Book a call Email us
contact@saunee.co