From Concept to Market
Through the Tentamus network, BDC Laboratories delivers world-class device testing while CardioMed Device Consultants provides expert FDA regulatory and preclinical testing strategy. Together, we offer comprehensive support across the medical device lifecycle.
Global Expertise
From concept through device approval and market launch, BDC Laboratories and CardioMed Device Consultants work together to support medical device development with technical precision and regulatory awareness.
Since 2003, medical device manufacturers worldwide have relied on CardioMed Device Consultants to navigate every stage of the product lifecycle, from early development and regulatory planning to submission strategy, risk management, and post-market support.
With over 100 years of combined experiences in medical device development, evaluation, and regulatory review, the team offers deep practical insight into FDA processes and expectations. CardioMed’s expertiese spans a broad spectrum of technologies, including endovascular devices, other medical devices, and digital health solutions.
BDC Laboratories partners with leading medical device companies to support new implantable devices and their delivery systems through testing services, test systems, and silicone vessels and simulations for R&D, training, and demonstrations.
With more than 30 years of experiences in cardiovascular devices, a GLP compliant quality system, and ISO/IEC 17025 accreditation, BDC delivers reliable data under rigourous standards while maintaining the flexibility to evaluate both established technologies and first-of-their-kind innovations.
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
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
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.