From Concept to Market
Serving medical device manufacturers worldwide, BDC Laboratories and CardioMed Device Consultants deliver comprehensive support across the total product lifecycle of Class II and III medical devices.
Uniquely Comprehensive Service
Medical device manufacturers worldwide have relied on BDC Laboratories and CardioMed Device Consultants to navigate every stage of the product lifecycle, from concept through device approval and market launch. Few partners can offer this breadth of regulatory and testing support under one roof. With more than 200 years of combined experience, our teams support medical device development with a rare pairing of technical precision and regulatory insight — all under one coordinated engagement.
Our collaboration means:
We work with your team throughout the full product development cycle.
From early design through submission, CardioMed leads the regulatory consulting and develops a testing approach and plan, drawing on a team of former FDA employees who know the ins and outs of the approval process.
BDC works from initial feasibility testing through regulatory submission and into production tests. Active participation in AAMI, ISO, and ASTM standards committees gives the BDC team unique insight into developing plans and protocols for FDA and CE Mark submissions.
We become an extension of your team
CardioMed + BDC acts as a force multiplier. With large organizations, this means we work with in-house regulatory and R&D teams. With small companies and startups, CardioMed + BDC become the team that takes care of regulatory strategy and testing services.
Our combined expertise and experience make us agile in bringing novel technologies to market
Novel devices carry distinct regulatory complexity and can take three to ten years to reach market depending on risk class and device classification. You need a team who has seen it all to help guide you through this complex process.
We serve a wide range of customers, from start-ups to multinational corporations
Organizations with vastly different resources have different requirements for regulations and testing support. We understand the obstacles you will face and the best ways to overcome them.
Complementary Expertise
CardioMed Device Consultants
FDA regulatory strategy and submission support
Guidance on FDA preclinical testing requirements (Class II and Class III)
Expertise from former FDA CDRH reviewers
Specialized support for startups and international manufacturers
Broad spectrum of technologies, including endovascular devices and digital health solutions
BDC Laboratories
Mechanical and functional device testing
Regulatory submission testing (Class II and III)
Custom test protocols, equipment and simulation systems
Comprehensive device testing reports
GLP compliant
ISO/IEC 17025 accredited
A Global Partner for Analysis Safety and Consultancy
Our parent company, Tentamus, offers a global network of highly specialized laboratories equipped to ensure the quality and safety of tested goods. To maintain this network, Tentamus actively participates in product- and industry-specific knowledge centers, unifying skills and expertise from across industries.
Each laboratory is a frontrunner in its field, and together they form a global network designed to meet the increasingly complex customer demands of our customers. Through this integration, Tentamus provides global solutions with local points of contact. To further support clients, Tentamus also offers on-site services that enable rapid verification of product safety and quality across the life science sector.
BDC Laboratories joined the Tentamus network in 2017, expanding its medical device testing and simulation capabilities. CardioMed followed in 2024, further strengthening Tentamus’ integrated medical device expertise.