Tentamus Group BDC Laboratories

About Us

Your medical device consulting partner since 2003.

CardioMed Device Consultants (CMDC) brings together regulatory, preclinical, clinical and quality expertise to guide medical device companies across the total product life cycle, from strategy to market success.

Our Mission

Dedicated to advancing medical device development.

CardioMed Device Consultants was founded to give medical device companies the regulatory, clinical and technical expertise that genuinely moves programs forward, without the overhead of a large CRO or the gaps of a generalist consultancy.

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

Whether you need regulatory strategy, clinical trial support, preclinical testing guidance or quality system design, CMDC works as an extension of your team: hands-on, expert-led and invested in your program’s success.

Our Core Values

Four commitments behind every engagement.

Expert-led, every time

Every engagement is led and carried out by experienced professionals with direct regulatory, clinical and technical expertise.

Regulatory precision

Deep knowledge of FDA regulations, combined with practical experience across the device life cycle, from pre-market through post-approval.

Integrated strategy

Regulatory, preclinical, clinical and quality considerations are never siloed, so gaps are caught early and programs keep moving.

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 CMDC

What sets CMDC apart.

Former FDA staff on your team

We know how review teams think, what they'll ask and how to answer, from Pre-Submission through approval.

Expertise across the total product life cycle

Regulatory, preclinical testing, clinical and quality experts under one roof, before and after approval.

High-risk device experience

Class II and Class III devices, including implantable and interventional technologies, where getting it right matters most.

A consulting partner on your side

We advise and oversee rather than sell trials or tests, recommending the labs, CROs and specialists that fit your program.

Leadership

The people leading CMDC.

Meet our consultants →

CMDC + BDC Laboratories

Regulatory consulting and device testing under one roof.

Together with BDC Laboratories, we support Class II and Class III devices from feasibility testing through submission and production.

Ready to advance your device program?

Tell us about your device and timeline.