From concept to market.

CardioMed Device Consultants and BDC Laboratories support manufacturers of Class II and Class III medical devices worldwide across the full product life cycle, with regulatory consulting and device testing under one roof.

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One Coordinated Team

Uniquely comprehensive service.

CMDC and BDC Laboratories bring regulatory support and device testing together in a single, coordinated engagement. With more than 200 years of combined experience, our teams pair technical precision with regulatory insight, so your testing and your regulatory strategy are planned together from the start.

CMDC leads regulatory consulting and planning, drawing on former FDA staff, from early design through submission. BDC Laboratories supports your program from initial feasibility testing through regulatory submission and production testing.

Our Collaboration

What working with CMDC and BDC means for you.

Support across the full development cycle

CMDC guides your regulatory path while BDC delivers the testing. BDC staff take an active part in AAMI, ISO and ASTM standards committees, which informs their FDA and CE Mark test plans and protocols.

An extension of your team

We work alongside in-house regulatory and R&D teams at large organizations, and act as the full regulatory and testing function for smaller companies and start-ups.

Agility with novel technologies

Novel devices bring distinct regulatory complexity and can take three to ten years to reach market, depending on risk and classification. Our combined experience helps you move with confidence.

Start-ups to multinationals

Every client has different resources and needs. We understand the obstacles you face and tailor regulatory and testing support to fit.

Complementary Expertise

Regulatory strategy and device testing, side by side.

Regulatory Consulting

CardioMed Device Consultants

FDA regulatory strategy and submission support
Guidance on FDA preclinical testing requirements for Class II and Class III devices
Expertise from former FDA CDRH reviewers
Support for start-ups and international manufacturers
A broad range of technologies, including endovascular devices and digital health solutions

Device Testing

BDC Laboratories

Mechanical and functional device testing
Regulatory submission testing for Class II and III devices
Custom test protocols, equipment and simulation systems
Comprehensive device testing reports
GLP compliance
ISO/IEC 17025 accreditation

Connect with an Expert

Talk to the right team for your program.

Contact CMDC Contact BDC Laboratories