About Medicept

We help bring your medical technologies to the patients who need them.

Medicept partners with medical technology companies navigating complex regulatory, quality, clinical, and commercialization challenges. Our team combines senior-level expertise with hands-on execution to help organizations move forward with greater confidence at every stage of the product lifecycle.

We approach every engagement with a clear sense of purpose: helping our clients deliver technologies that patients are waiting for.

Talk to an Expert
medical device consulting

One Partner. Every Milestone.

In medtech, regulatory, quality, clinical, and commercialization strategies are most effective when they're aligned from the start. That alignment helps organizations reduce risk, avoid rework, and keep critical milestones moving forward.

Medicept was built to solve that. As your integrated lifecycle partner, we bring all four disciplines together in one team, eliminating costly gaps, reducing risk, and keeping critical programs moving forward. Because patients are waiting.

consulting with doctor
"What I value most about Medicept is our commitment to being a trusted extension of our clients' teams. We bring practical experience, collaborative problem-solving, and a focus on delivering right-sized solutions that align with each client's unique challenges, goals, and long-term success."
Carolyn Russell
Carolyn Russell
VP Technical Services, QARA

For more than 30 years, we've brought experienced regulatory, quality, clinical, and operational experts together under one roof, so our clients have a single, accountable partner from early development through commercialization.

But our work isn't ultimately about submissions, audits, or milestones. It's about helping innovative medical technologies reach the patients who need them. At the center of every project we support is a patient who may one day depend on the technology being developed. That responsibility guides how we work and the standards we hold ourselves to.

30+ Years Supporting Medtech Innovation
RAC, ASQ, & ISO 13485-Certified Professionals
Supporting U.S. & Global Commercialization Programs
Senior-Level Regulatory, Quality & Clinical Experts
Integrated Regulatory, Quality & CRO Expertise
Class I, II, III Device Coverage — Experience spanning the full regulatory risk spectrum.
Dashboard-Driven Approach — Real-time visibility into submissions and program status, not black-box consulting.
14 Therapeutic Areas — From AI/ML and digital health to orthopedics, cardiovascular, and surgical systems.
Advanced Technology Focus — Proven work in SaMD, AI/Machine Learning, medical imaging, and implantable devices.

What Sets Us Apart

We Operate Like Part of Your Team

Our clients work directly with experienced professionals who become deeply familiar with their products, teams, and objectives — not a rotating roster of generalists.

We Combine Strategy With Execution

We help define the path forward, then work alongside clients to implement it. Advice without accountability isn't enough.

We Connect Regulatory, Quality, and Clinical Expertise

Our integrated regulatory, quality, and clinical teams reduce the fragmentation that derails timelines and weakens decision-making across the product lifecycle.

We Focus on Long-Term Success

Our work is designed to support sustainable commercialization. We ensure every stakeholder understands not just what was implemented, but why it was implemented and how it creates value beyond the immediate challenge.

Culture & Values

The Principles That Guide Our Work

Purpose-Driven Partnering

We improve patients' lives by empowering clients to bring safe, effective, and innovative medical technologies to market.
Purpose-Driven Partnering

Mastery in Execution

We compete on expertise, precision, and disciplined execution.
Mastery in Execution

Integrity in Action

We do what's right through accountability, transparency, and trust.
Integrity in Action

Intentional Focus

We invest our time and talent where they create the greatest impact for clients and patients.
Intentional Focus
"At Medicept, our people are our greatest strength. We've built a culture where expertise, collaboration, and integrity come together to support both our employees and our clients."
Lisa Wagner
Lisa Wagner
VP, Human Resources

Leadership Perspectives

Every one of these principles exists for the same reason. Patients are waiting, and the work we do affects how quickly they get access to the technologies that can help them.

"Medicept is built around bringing strategy and execution together. Our clients are not looking for generic recommendations — they need experienced partners who can solve complex problems, move critical initiatives forward, and understand the operational realities of bringing products to market."
Jason Gromek

Jason Gromek

President & CEO

"At Medicept, consulting is not transactional. It is a partnership built on trust, solutions, and measurable impact. Any firm can fix a problem. Medicept builds lasting, right-sized solutions — and ensures every stakeholder understands why they work and how they create sustainable success beyond the immediate challenge."
F. David Rothkopf

Dave Rothkopf

Founder

Ready To Move Forward?

Whether you're preparing for a submission, building a quality system, launching a clinical program, responding to an FDA challenge, or scaling commercialization efforts, Medicept can help.

Patients are waiting. Let's make sure you're ready to reach them.