The QA/RA Team Your Milestones Need. Not the Headcount.
Patients are waiting. Get senior regulatory and quality leadership, embedded in your team and backed by Medicept’s integrated regulatory, quality, clinical, and commercialization experts, sized to the stage your company is in.
You Raised Capital To Reach Patients. Not To Build a Department.
Every month of runway is spoken for. Yet the path from FDA clearance to commercialization runs through regulatory and quality work that demands senior judgment, in more specialties than any single hire can cover. So companies end up choosing between two bad options: hire a full-time executive before the workload justifies it, or stretch a founder and a junior hire until something gives.
Sound Familiar?
Your regulatory strategy lives in one person’s head, or in a founder’s evenings.
You need a VP of QA/RA, but not full-time, and not for another year.
Your quality system was built to pass a checklist, and an audit or investor diligence is approaching.
The workload triples around a submission, then falls away.
Consultants hand you documents. Nobody owns the outcome.
Your board asks whether you are on track with FDA, and the answer is a guess.
Add Expertise Without Expanding Your Team
Fractional QA/RA gives you an experienced regulatory and quality team that works inside your company for the share of time you need. A senior lead joins your leadership meetings, owns your regulatory and quality roadmap, and is accountable for your milestones. Behind that lead sits a full bench of specialists who step in when the work calls for them.
It is not a project consultant who leaves when the document is delivered. It is not a contractor filling a seat. It is embedded support that integrates with your team and stays invested in your product’s future.
What You Need Changes as You Grow. We Change With You.
Series A: Achieve FDA Clearance.
You are approaching design freeze and your first FDA conversation. We help you define your regulatory pathway, make every Pre-Submission count, and build a quality foundation that fits your stage, so you avoid costly rework later.
Series B: Be Ready When It Counts.
Your pivotal study, submission, and first audits arrive at once. We add specialists exactly when the workload peaks, then step back when it eases, so your team is never overextended and never overstaffed.
Series C: Stay Focused on Commercialization.
Launch, new markets, a second product, and investor or acquirer diligence. We help you meet post-market obligations, expand into global markets, and show a quality system that scales with your business.
One Integrated Partner for the Full Lifecycle
Embedded Support That Integrates With Your Team
One senior lead who knows your product, your people, and your board commitments, and stays with you from one milestone to the next.
Leadership Backed by Integrated Expertise
The specialist you need next month is already a colleague of the lead you have today, across regulatory, quality, clinical, and commercialization.
Strategy and Hands-On Execution
The same team defines the plan and does the work, so nothing is lost between the advice and the delivery.
Flexible Leadership Without Permanent Hiring
More support through a submission, an audit, or a launch, and less when the pressure eases.
Clear Visibility at Every Milestone
Dashboard reporting gives you and your board real-time visibility into status, risks, and next steps. Not black-box consulting.
What Changes for You
Without It
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Runway spent on a senior hire before the workload justifies it
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Months spent recruiting while the timeline slips
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One person, one set of skills, one point of failure
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Rework when regulatory, quality, and clinical plans collide
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Gaps found during diligence or inspection
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Uncertainty in the boardroom
With Medicept Fractional QA/RA
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Capital stays with the product; QA/RA cost follows the work
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Rapid access to experienced leadership, with no search
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A full team, with continuity if anyone is unavailable
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One aligned plan, so critical programs keep moving
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A quality system that is ready, tested, and proven
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Confidence, backed by visible progress
The Net Benefit: You reach your next milestone sooner and with less risk, on the capital you already have. When the time comes to build an in-house team, we help you hire it and hand over a quality system that works.
“They worked as an extension of our department. When product approval came and auditors arrived, the system was ready, tested, and proven.”
Trena Depel
VP, Regulatory, Clinical, Quality, Teal Health Inc.
Three Steps to Your Next Milestone
Talk to an Expert.
A 30-minute conversation about your product, your stage, and your next milestone. You leave with a clear view of what regulatory and quality support you need now, and what can wait.
Your Plan and Your Team.
We propose a senior lead, the specialists behind them, and a level of support matched to your roadmap.
We Get to Work.
Your lead joins your team, takes ownership of the regulatory and quality roadmap, and reports progress you can share with your board.
Move Critical Programs Forward
30+
Years Supporting Medical Devices
600+
Regulatory Submissions Supported
365+
Clinical Trials Led
Class I, II, and III device experience across 14 therapeutic areas
Complex medical technologies, including software, digital health, AI-enabled products, and combination products
Certified professionals: RAC Certified Regulatory Professionals, ASQ Certified Quality Professionals & Auditors, and ISO 13485 Certified Lead Auditors
Frequently Asked Questions
Fractional QA/RA is senior regulatory affairs and quality assurance leadership that works inside your company part-time. You get an experienced lead and a bench of specialists for the share of time your roadmap requires, instead of hiring a full-time executive and team.
Interim leadership fills a leadership role during a transition, such as a departure or a remediation. Fractional QA/RA is designed for growth-stage companies that need senior regulatory and quality leadership before the workload justifies a full-time hire. Medicept offers both.
Most companies benefit from it between their first FDA interaction and commercialization. Common triggers are defining a regulatory pathway, preparing a Pre-Submission, building a quality system, preparing a 510(k), De Novo, or PMA, facing a first audit or inspection, or preparing for investor diligence.
A consultant is usually engaged for a defined deliverable and then leaves. A fractional lead is embedded in your team, owns your regulatory and quality roadmap, and is accountable for outcomes across milestones.
For most early and growth-stage companies, the workload does not justify a full-time executive yet. Fractional support lets the cost follow the work, rising around a submission or audit and falling afterwards, so more of your capital stays with the product.
Yes. Medicept supports medical devices, software, digital health, AI-enabled products, and combination products across Class I, II, and III.
We help you define the roles, hire the right people, and hand over a working quality system, so the transition does not slow your program.
Yes. We help companies expand into global markets alongside their U.S. strategy, and our clinical leadership team has run trials across 25+ countries in North America, EMEA, APAC, and LATAM.
Patients Are Waiting. Let’s Get You to Your Next Milestone.
From regulatory strategy and quality systems to clinical evidence and commercialization, Medicept brings senior expertise into your team at the pace your company is growing. Talk to an expert about where your QA/RA program stands and what your next milestone needs.
Fill out the form to talk to an expert, or call 508-231-8842.