Part of the Tentamus Group
Who We Are

About CardioMed
Device Consultants

Senior expertise for complex medical device programs — from regulatory strategy to clinical execution and quality compliance.

Our Mission

Dedicated to Advancing Medical Device Development

CardioMed Device Consultants was founded to provide medical device sponsors with the kind of senior-level regulatory, clinical, and technical expertise that can genuinely move programs forward — without the overhead of large CROs or the gaps of generalist consultants.

We specialize in Class II and Class III cardiovascular devices, including implantable and interventional technologies. Our team brings firsthand experience of FDA expectations, device review processes, and the nuances of complex, high-risk device programs.

Whether you need comprehensive regulatory strategy, end-to-end clinical trial management, pre-clinical testing guidance, quality system design, or targeted training, CardioMed operates as a true extension of your team — hands-on, senior-led, and deeply invested in your program's success.

Our Core Values

Senior-Led, Every Time
No hand-offs to junior staff. Every engagement is led and executed by experienced professionals with direct regulatory and clinical expertise.
Regulatory Precision
We combine deep knowledge of FDA regulations with practical experience across the full device lifecycle — from pre-market through post-approval.
Integrated Strategy
Clinical, regulatory, pre-clinical, and quality considerations are never siloed — our integrated approach prevents gaps and accelerates programs.
Partnership First
We work as an extension of your team, adapting to your needs and timelines with the flexibility and commitment of a true partner.
Why CardioMed

What Sets Us Apart

Deep FDA Experience

First-hand knowledge of FDA expectations, IDE processes, and device approval pathways, with direct relationships across CDRH cardiovascular device review teams.

Cardiovascular Device Focus

Specialized expertise in cardiovascular devices — including implantable, interventional, and combination products — demanding the highest level of precision and rigor.

Total Product Life Cycle

Support from early development strategy through post-market compliance — a continuous, integrated partnership for the full life of your device program.

Trusted Network

Access to a curated network of CROs, laboratories, and subject matter experts to complement our core capabilities and support specialized program needs.

Work With Us

Ready to Partner with
CardioMed?

Reach out to discuss your device program and how our team can provide the expertise you need.

Schedule a Consultation