BDC Laboratories

What BDC Laboratories does

BDC Laboratories is a specialized medical device testing laboratory based in Wheat Ridge, Colorado, operating as a US subsidiary of the Tentamus Group. The company provides ISO/IEC 17025:2017-accredited functional testing services for Class II and Class III cardiovascular implants — including heart valves, stents, stent grafts, catheters, guidewires, cardiac occluders, vascular grafts, and vena cava filters — supporting manufacturers' FDA and CE Mark regulatory submissions. BDC also designs, manufactures, and sells proprietary testing equipment (heart valve durability testers, pulse duplicators, pulsatile pumps, uniaxial and torsion fatigue systems, and the Statys GOA analysis software) and engineered silicone vasculature and full simulation systems for cardiovascular device development and physician training.

The business operates across three integrated revenue streams: professional testing services, proprietary equipment sales (with an international distributor network), and silicone-based simulation products with specialized coatings such as SLIC friction reduction. BDC differentiates through active participation in AAMI, ISO, and ASTM standards committees, giving it regulatory foresight into emerging standards, and through engineering expertise accumulated over 30+ years in cardiovascular device testing. Customer relationships are sticky, with over 70% of business from returning clients spanning enterprise manufacturers (Teleflex, Angiodynamics, BiO2 Medical) and earlier-stage device developers.

The go-to-market is consultative and technical: enterprise field sales targeting medical device R&D and regulatory affairs teams, supported by quote-based pricing, scientific literature, conference presence at events including MD&M Midwest and TCT, and digital channels (LinkedIn, YouTube). Through its Tentamus network affiliation, BDC bundles testing services with CardioMed Device Consultants to offer end-to-end medical device lifecycle support from preclinical testing through market launch.

Name

BDC Laboratories

Legal name

Biomedical Device Labs

Website

https://WWW.BDCLABS.COM

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

51–100 employees

Short description

BDC Laboratories is an ISO/IEC 17025-accredited medical device testing laboratory based in Wheat Ridge, Colorado, providing functional testing services, proprietary testing equipment, and silicone vascular simulations for cardiovascular implant manufacturers pursuing FDA and CE Mark regulatory submissions.

Ownership category

akta.pro rank

Product category

Medical Device Testing Services

NAICS

Medical Laboratories (621511), Testing Laboratories and Services (541380)

SIC

Services-Medical Laboratories (8071), Services-Testing Laboratories (8734)

akta.pro primary industry

Reference & Esoteric Testing Laboratories (HLAFAMAJ)

akta.pro secondary industry

Release Testing & Batch Certification (QC) (HLAGADAC)

Keywords

• Medical device testing
• Cardiovascular device testing
• Testing laboratory services
• Medical testing equipment
• Silicone vascular models

Headquarters

HQ city

Wheat Ridge

HQ country

United States

HQ region

North America

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Marketing or Sales

Revenue model

1. Testing Services: ISO/IEC 17025:2017 accredited functional testing services for medical devices including heart valves, stents, catheters, and other Class II and III implants. Services support FDA and CE Mark regulatory submissions.
2. Testing Equipment Sales: Sale of medical device testing equipment including heart valve systems, pulsatile durability testers, fluid handling systems, and related testing hardware. Equipment is rooted in academic research and built for industry R&D with adaptability and comprehensive monitoring.
3. Silicone Simulations: Sale of engineered silicone vasculature, anatomical models, mock vessels, and full simulation systems for cardiovascular device development and physician training.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

BDC Laboratories is a specialized medical device testing laboratory that delivers ISO/IEC 17025:2017-accredited functional testing services for cardiovascular implants (heart valves, stents, catheters, guidewires, occluders, vascular grafts, vena cava filters). The company also manufactures proprietary testing equipment (heart valve durability testers, pulse duplicators, pulsatile durability systems, fluid handling systems) and produces engineered anatomical silicone vasculature and full simulation systems used for device development, preclinical testing, and physician training.

Product overview

BDC Laboratories provides a comprehensive portfolio of medical device testing solutions comprising three core offerings: Testing Equipment (precision test systems for heart valve, cardiovascular, and materials testing including VDT-3600i, RWT-4600i, HDTi-6000, RDT-7600i, LDT-1800, TT-2600i, and various pulsatile pumps), Testing Services (ISO/IEC 17025:2017-accredited functional testing for heart valves, stents, catheters, guidewires, occluders, vascular grafts, and vena cava filters, plus universal tests for MRI compatibility, coating integrity, fatigue, and corrosion), and Silicone & Simulations (engineered anatomical and non-anatomical silicone vessels with specialized coatings and full simulation systems for device testing and physician training). The company operates under the Tentamus Group and partners with CardioMed Device Consultants to deliver end-to-end support across the medical device lifecycle.

Differentiator

Problem solved

Functional benefit

Brands

• CardioMed Device Consultants: Partnership within Tentamus network providing end-to-end support across medical device lifecycle from preclinical testing to regulatory strategy and market launch.

Products and services

• VDT-3600i Heart Valve Durability Tester Heart valve durability testing system designed to evaluate the long-term performance and structural integrity of heart valve implants under simulated physiological conditions. Sold to medical device manufacturers and cardiovascular implant R&D teams.
• RWT-4600i Heart Valve Real Time Wear System Real-time wear testing system for heart valve durability assessment under continuous physiological loading conditions. Targets cardiovascular implant manufacturers and R&D laboratories.
• HDTi-6000 Heart Valve Pulse Duplicator Advanced pulse duplicator system for hydrodynamic testing of heart valve devices under pulsatile flow conditions. Targets cardiovascular device manufacturers performing hydrodynamic performance testing.
• Statys GOA Heart Valve Analysis Software Proprietary software for heart valve analysis, providing automated assessment and reporting of valve performance metrics during durability and hydrodynamic testing. Targets cardiovascular implant R&D and quality teams.
• SFT-1000 Heart Valve Steady Flow System Steady flow testing system for evaluating heart valve performance under constant flow conditions. Targets cardiovascular device manufacturers and R&D laboratories.
• PQT-5000 Heart Valve Production System Production-quality testing system for heart valve manufacturing validation and quality control. Targets heart valve manufacturers for production-line and quality assurance testing.
• RDT-7600i Pulsatile Durability Test System Pulsatile durability testing system for cardiovascular devices, simulating physiological pressure and flow cycles for radial and uniaxial fatigue testing. Targets cardiovascular device manufacturers.
• LDT-1800 Uniaxial Fatigue System Uniaxial fatigue testing system for evaluating material strength and durability under cyclic loading conditions. Targets medical device manufacturers performing material fatigue testing.
• TT-2600i Torsion Fatigue & Durability System Torsion fatigue testing system for assessing rotational stress durability of medical devices. Targets medical device manufacturers requiring torsional durability testing.
• PD-1100 Pulsatile Pump System Pulsatile pump for generating physiological-like pressure waveforms in cardiovascular testing applications. Targets cardiovascular testing laboratories and device manufacturers.
• PD-0750 Portable Pulse Duplicator Portable pulse duplicator for on-site or mobile cardiovascular device testing applications. Targets medical device manufacturers and field-testing operations.
• PD-0500 Portable Pulse Duplicator Compact portable pulse duplicator for smaller-scale cardiovascular device testing needs. Targets medical device manufacturers and testing laboratories with limited bench space.
• PD-0250 Portable Oscillating Pump Portable oscillating pump for generating pulsatile flow in physiological testing simulations. Targets medical device testing laboratories and cardiovascular R&D teams.
• TCU-1 Heated Circulator Bath Temperature control unit for maintaining physiological temperatures during cardiovascular device testing. Targets cardiovascular testing laboratories and device manufacturers.
• Heart Valve & Valve Repair Device Testing Services Comprehensive functional testing services for heart valve implants and repair devices under ISO/IEC 17025:2017 accreditation, supporting FDA and CE Mark submissions. Targets cardiovascular implant manufacturers.
• Stent & Stent Graft Testing Services Durability and performance testing services for vascular stents and stent grafts under ISO/IEC 17025:2017 accreditation. Targets vascular implant manufacturers.
• Catheter Testing Services Functional and durability testing services for catheter devices including navigation and torqueability assessment. Targets catheter manufacturers and interventional cardiovascular device companies.
• Guidewire & Dilator Testing Services Mechanical testing services for guidewires and dilators used in interventional cardiovascular procedures. Targets interventional device manufacturers.
• Cardiac Occluder Testing Services Specialized testing for cardiac occluder devices including structural integrity and deployment assessment. Targets structural heart device manufacturers.
• Vascular Graft Testing Services Durability and performance testing for vascular graft implants under simulated physiological conditions. Targets vascular graft manufacturers.
• Vena Cava Filter Testing Services Testing services for vena cava filters including fatigue, corrosion, and deployment performance. Targets manufacturers of inferior vena cava (IVC) filtration devices.
• MRI Compatibility Testing Services MRI safety and compatibility testing to evaluate device behavior under magnetic resonance imaging conditions. Targets medical device manufacturers needing MR-conditional labeling.
• Coating Integrity & Acute Particulate Testing Services Testing services for evaluating coating durability and identifying particulate generation from medical devices. Targets medical device manufacturers with coated or surface-treated implants.
• Material Fatigue Strength Testing Services Material characterization and fatigue strength testing for medical device materials and components. Targets medical device manufacturers performing materials qualification.
• Medical Device Corrosion Testing Services Corrosion resistance testing for medical devices to ensure long-term safety and performance. Targets medical device manufacturers requiring corrosion validation for implants and instruments.
• Anatomical Silicone Vessels High-fidelity anatomical silicone vessels replicating human vasculature for cardiovascular device testing and physician training. Targets medical device manufacturers, R&D teams, and physician training programs.
• Full Simulation Systems Complete anatomical simulation systems including vessels and surrounding tissue structures for realistic cardiovascular device testing. Targets medical device manufacturers and training institutions.
• Non-Anatomical Silicone Vessels Standardized silicone vessel phantoms including straight, U-vessel, and bifurcated configurations for general testing applications. Targets medical device manufacturers performing routine device testing.
• SLIC Friction Reduction Coating Proprietary friction reduction coating applied to silicone vessels to simulate realistic tissue-device interaction. Targets medical device manufacturers using silicone-based testing systems.
• Echogenic Treatment Treatment enhancing ultrasound visibility of silicone vessels for imaging-guided device testing. Targets medical device manufacturers performing imaging-guided procedure testing.
• Calcification Simulation Simulated calcified vessel conditions for testing devices in pathologically challenging environments. Targets medical device manufacturers needing realistic pathological anatomy models.
• Fluid Handling Systems for Physiological Flow Simulation Integrated fluid handling systems designed to create realistic physiological flow conditions in simulation environments. Targets medical device manufacturers and simulation laboratories.
• Medical Device Training Tools Silicone-based training systems for physician education and skill development in cardiovascular device procedures. Targets medical training institutions and physician education programs.
• Equipment Care Program Maintenance and support program for BDC Laboratories testing equipment ensuring optimal performance and longevity. Targets existing testing equipment customers.

Quantifiable outcome

• 70%+ of business is from returning clients

Named customers10 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Three partnerships are on record, tiered core.

• Dilawri Cardiovascular InstitutecoreStrategic or Co-development Partner · 16 December 2025Collaboration with Dilawri Cardiovascular Institute to enhance cardiovascular device testing capabilities. The partnership aims to advance testing methodologies and expand industry partnerships for medical device development.
• CardioMed Device ConsultantscoreStrategic or Co-development PartnerCardioMed Device Consultants provides end-to-end support across the medical device lifecycle from preclinical testing and regulatory strategy to market launch through the Tentamus network partnership with BDC Laboratories.
• Tentamus GroupcoreStrategic or Co-development PartnerParent company through which BDC Laboratories operates, providing network resources and collaborative capabilities across medical device testing and consulting services globally.

Scale indicators3 records

Recent moves5 records

Expansion highlights3 records

Direct peers

• NAMSA: NAMSA is the largest contract research organization dedicated exclusively to medical devices, offering biocompatibility, sterility, and functional testing services plus consulting for FDA submissions — directly comparable to BDC's ISO 17025-accredited cardiovascular testing services and regulatory submission support.
• Nelson Labs (Sotera Health): Nelson Labs provides medical device and pharmaceutical laboratory testing services including sterility, biocompatibility, and packaging — a directly comparable accredited testing-services peer serving the same Class II/III medical device manufacturers as BDC.
• Med Institute: Med Institute provides contract research, testing, and regulatory services for medical devices including cardiovascular implants — a directly comparable niche peer offering testing and submission support to the same customer base as BDC.
• Toxikon: Toxikon is a contract medical device testing laboratory offering preclinical and device performance testing services, including extractables/leachables and biocompatibility — overlapping with BDC's functional and fatigue testing for cardiovascular implant manufacturers.
• TÜV SÜD America: TÜV SÜD provides medical device testing, certification, and regulatory support globally — directly competing with BDC for accredited functional testing and FDA/CE Mark submission-related testing work from cardiovascular manufacturers.

Broad incumbents

• WuXi AppTec Medical Device Testing: WuXi AppTec operates a global CRO with medical device testing capabilities alongside broader pharmaceutical and biologics services — a broad incumbent that increasingly competes for outsourced medical device testing engagements with BDC's customer base.
• Intertek Medical: Intertek offers medical device testing and certification services globally across multiple disciplines — a broad-incumbent peer providing competing accredited testing for cardiovascular manufacturers, though with less specialized focus.
• SGS Medical Device Services: SGS provides medical device testing, certification, and regulatory services on a global scale — a broad incumbent that competes for the same medical device manufacturer testing contracts but offers a wider portfolio beyond cardiovascular specialization.
• Charles River Laboratories: Charles River Laboratories is a large CRO with a Medical Device and Combination Products services group — a broad incumbent offering testing, biocompatibility, and consulting support that overlaps with BDC's ISO 17025-accredited cardiovascular testing workflow.
• Eurofins Medical Device Testing: Eurofins operates a broad network of medical device testing laboratories covering biocompatibility, microbiology, and chemistry — a larger incumbent offering overlapping test panels and competing with BDC for global cardiovascular manufacturer engagements.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/@bdclaboratories8571
• LinkedInlinkedin.com/company/bdc-laboratories

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds

Investors

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

M&A

Investments4 records

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

Frequently asked questions about BDC Laboratories