CardioMed Device Consultants

What CardioMed Device Consultants does

CardioMed Device Consultants is a specialized medical device consulting firm headquartered in Edgewater, Maryland, that provides regulatory, clinical, pre-clinical, quality systems, and customized training services to medical device manufacturers, with particular depth in Class II and Class III cardiovascular devices including implantable, interventional, and combination products. The firm operates as a senior-led professional services practice without junior handoffs, leveraging firsthand FDA experience among its principal consultants—several of whom are former FDA reviewers from the Office of Device Evaluation and Office of Science and Technology—to guide sponsors through FDA pathways (IDE, 510(k), PMA, De Novo), Breakthrough Device Designation, and the TAP Pilot program. CardioMed is a subsidiary of the Tentamus Group, an international network of laboratories and consulting firms, and works in coordination with affiliated BDC Laboratories.

The firm delivers five core service lines: Clinical Trial Services (trial design, vendor oversight, GCP compliance), Regulatory Consulting Services, Pre-Clinical Consulting Services (biocompatibility, animal studies, risk assessments), Quality Systems & Manufacturing Consulting (FDA QSR and ISO 13485 alignment), and Customized Training Programs. Revenue is generated through project-based professional services engagements with rates determined by scope, complexity, and senior consultant involvement; pricing is not publicly disclosed. The firm maintains a curated network of CROs, specialized laboratories, and subject matter experts to extend execution capacity. Customer acquisition runs through direct consultation requests, conference networking at industry events such as EuroPCR and CRT, and the firm's informational website, targeting device sponsors ranging from startups to established manufacturers.

Name

CardioMed Device Consultants

Legal name

CardioMed Device Consultants

Website

https://cardiomedllc.com

Company type

Private

Founded year

2003

Operating status

Operating

Headcount range

11–50 employees

Short description

CardioMed Device Consultants is a senior-led medical device consulting firm providing regulatory, clinical, pre-clinical, quality systems, and training services to Class II and Class III cardiovascular device manufacturers, operating as a subsidiary of the Tentamus Group.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory & Clinical Consulting

NAICS

Other Scientific and Technical Consulting Services (54169), Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

akta.pro secondary industry

Clinical Research Support (CRC/CTA) (EDAOAJAO)

Keywords

• Medical device consulting
• Regulatory affairs consulting
• Clinical trial services
• Quality systems consulting
• FDA submission support

Headquarters

HQ city

Edgewater

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Marketing or Sales, Operations, Others

Revenue model

1. Regulatory Consulting Services: Consulting fees for regulatory strategy development, FDA submission preparation, and regulatory pathway navigation for medical device manufacturers across IDE, 510(k), PMA, and De Novo pathways.
2. Clinical Trial Services: End-to-end clinical program execution including trial design, vendor oversight, GCP compliance, and audit readiness for IDE, PMA, and 510(k) programs.
3. Pre-Clinical Consulting Services: Expert engineering and scientific advice on non-clinical testing strategies, biocompatibility, animal studies, and specialized medical device risk assessments.
4. Quality Systems Consulting Services: Design and optimization of quality systems aligned with FDA QSR and ISO 13485, including inspection readiness, CAPA, and manufacturing compliance.
5. Customized Training Programs: FDA-aligned training programs for regulatory, clinical, and engineering teams covering FDA frameworks, submission pathways, and testing strategy.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels4 records

Core offering

CardioMed Device Consultants is a medical device consulting firm that provides integrated regulatory, clinical, pre-clinical, and quality systems consulting services to manufacturers of Class II and Class III medical devices, with particular focus on cardiovascular implantable and interventional technologies. The firm guides sponsors through FDA regulatory pathways (IDE, 510(k), PMA, De Novo, Breakthrough Device Designation, TAP), designs and oversees clinical trials, advises on pre-clinical testing strategies, designs ISO 13485 and FDA QSR-compliant quality systems, and delivers customized FDA-aligned training programs across the Total Product Life Cycle.

Product overview

CardioMed Device Consultants is a consulting firm that provides integrated medical device consulting services across the total product lifecycle for Class II and Class III cardiovascular devices. The firm offers five core service offerings: Clinical Trial Services (strategic, end-to-end clinical support including trial design, vendor oversight, and GCP compliance), Regulatory Consulting Services (regulatory strategy and execution covering IDE, PMA, 510(k), and Breakthrough Device Designation), Pre-Clinical Consulting Services (non-clinical testing strategy, biocompatibility, animal studies, and engineering evaluation), Quality Systems & Manufacturing Consulting (quality systems aligned with FDA QSR and ISO 13485), and Customized Training Programs (FDA-aligned training for regulatory, clinical, and engineering teams). These services are delivered by senior-led teams with deep FDA experience and are designed to work together as an integrated offering rather than as isolated consulting engagements.

Differentiator

Problem solved

Functional benefit

Products and services

• Regulatory Consulting Services Translation of company goals into clear regulatory strategies and achievable milestones across the full Total Product Life Cycle, from IDE through post-market, covering FDA pathways including 510(k), PMA, De Novo, Breakthrough Device Designation, and the TAP Pilot. Targeted at Class II and Class III medical device manufacturers, with depth in cardiovascular, interventional, and combination product sponsors.
• Clinical Trial Services Strategic, end-to-end clinical support for medical devices including trial design, vendor oversight, GCP compliance, and audit readiness for IDE, PMA, and 510(k) programs. Aimed at medical device sponsors requiring senior-led clinical program execution across the cardiovascular and broader medical device space.
• Pre-Clinical Consulting Services Expert engineering and scientific advice on non-clinical testing strategies, biocompatibility, animal studies, and specialized medical device risk assessments, with emphasis on cardiovascular devices including stents, heart valves, vascular grafts, and combination products.
• Quality Systems & Manufacturing Consulting Design and optimization of quality systems aligned with FDA QSR and ISO 13485, including inspection readiness, CAPA, and manufacturing compliance for medical device manufacturers. Targeted at sponsors scaling Class II/III device programs through pre-market and post-market phases.
• Customized Training Programs Practical, FDA-aligned training programs for regulatory, clinical, and engineering teams covering FDA frameworks, submission pathways, testing strategy, and device lifecycle requirements. Designed for medical device sponsor teams needing to build internal regulatory and technical capability.

Quantifiable outcome

• CardioMed client accepted into FDA TAP Pilot after receiving Breakthrough Device Designation

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Partnerships

Three partnerships are on record, tiered core.

• Tentamus GroupcoreOthersCardioMed Device Consultants is part of the Tentamus Group, an international network of laboratories and consulting firms serving the medical device, pharmaceutical, and consumer products industries. The partnership provides CardioMed with access to broader regulatory consulting capabilities and a global network of testing laboratories and technical experts.
• BDC LaboratoriescoreTechnology or IntegrationBDC Laboratories is listed as an affiliated organization within the CardioMed/Tentamus Group network. The firms collaborate on medical device testing services, with CardioMed referring clients to BDC Laboratories for specialized device testing capabilities. CardioMed maintains booth presence alongside BDC Laboratories at industry conferences such as EuroPCR.
• Curated Network of CROs and Specialized LaboratoriescoreStrategic or Co-development PartnerCardioMed maintains a curated network of trusted CROs, specialized laboratories, and subject matter experts supporting clinical execution, data management, biostatistics, and advanced device testing. The firm connects clients with high-quality providers tailored to their program needs, ensuring efficient, reliable, and quality-assured execution across all phases of development.

Scale indicators1 record

Recent moves7 records

Expansion highlights4 records

Direct peers

• NAMSA: NAMSA is the largest pure-play medical device-focused CRO, offering regulatory, clinical, and laboratory services for Class II/III devices. It is the most direct scaled competitor to CardioMed across cardiovascular and high-risk device programs.
• Exponent: Exponent is a scientific and engineering consulting firm with a large medical device practice covering regulatory strategy, failure analysis, and biomechanics. CardioMed CEO Jasmine Patel previously worked at Exponent, and the firms compete for the same engineering-led regulatory consulting engagements.
• RCRI (Regulatory & Clinical Research Institute): RCRI provides regulatory, clinical, and quality consulting specifically for medical device manufacturers, including cardiovascular and combination products. Closely mirrors CardioMed's boutique, FDA-experienced senior-consultant model.
• Biologics Consulting Group: Biologics Consulting Group is a regulatory and product development consulting firm with significant medical device and combination product expertise, frequently engaging former FDA staff. Competes for the same Class II/III device regulatory mandates.
• FDA Quality and Regulatory Consultants (FDAQRC): FDAQRC specializes in FDA regulatory, quality systems, and compliance consulting for medical device and pharma manufacturers, with deep former-FDA expertise. Direct boutique competitor in the same FDA pathway advisory niche.
• BDC Laboratories: BDC Laboratories is a sister entity within the Tentamus Group providing medical device testing, including cardiovascular and structural heart testing. Operates as both an affiliate and a closely adjacent peer in the cardiovascular device services ecosystem.
• MDC Associates: MDC Associates is a medical device regulatory and quality systems consulting firm focused on FDA submissions, QSR compliance, and clinical strategy. A similarly sized boutique competitor for cardiovascular device sponsors.

Broad incumbents

• Parexel International: Parexel is a global CRO with an established medical device and regulatory consulting practice serving large cardiovascular device sponsors. A broad incumbent competing on global delivery capacity rather than niche specialization.
• Charles River Laboratories: Charles River offers medical device and diagnostic CRO services through its Safety Assessment and CDMO segments, serving cardiovascular and combination product clients. A scaled incumbent with broader portfolio reach.
• IQVIA: IQVIA is the largest global CRO with a dedicated medical device and regulatory affairs practice serving cardiovascular and high-risk device sponsors. Sets the competitive ceiling on scale, geographic reach, and pricing pressure CardioMed faces.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CardioMed Device Consultants