BDC Laboratories partners with leading medical device companies to support new implantable devices and their delivery systems with testing services, test systems, and silicone simulations. Rooted in academic research and built for industry R&D, BDC Laboratories’ test equipment offers ultimate adaptability, comprehensive sample monitoring, and data-rich testing environments. BDC Laboratories’ scope of ISO/IEC 17025:2017 accreditation spans functional testing of major medical devices, backed by decades of engineering expertise and active AAMI, ISO, and ASTM participation. BDC Laboratories leads in engineered silicone vasculature, delivering compliant mock vessels, anatomical models, and full simulation systems for cardiovascular device development. BDC Laboratories and CardioMed Device Consultants work together to give medical device manufacturers worldwide a single source of end-to-end support - from regulatory strategy through functional, engineering-based testing, and MedicGLP Website from first concept to market launch and beyond. We become an extension of your teams. For large organizations, we work alongside your in-house regulatory, quality, and R&D staff.
For smaller organizations and startups, we take on those roles completely. Either way, the approach and support are tailored to your resources, your technology, and your phase of development. GLP-compliant, and later additional ISO/IEC 17025:2017-accredited quality system - we have both the credentials and the experience to move you forward, whether you are bringing a novel device to market, introducing a new generation of existing technology, or managing a global submission portfolio. I have had multiple experiences working with BDC Labs on new catheter indication testing, and support was provided throughout the entire process. Technical support was given in designing the appropriate method, critical timeline needs were promptly met when required and data analysis discussion were available upon testing completion. I would highly recommend BDC Labs to companies requiring assistance in technical testing outside of the scope of their current capabilities. The services are professional and the data is reliable.
The reports generated were easy to understand and are defendable to regulatory authorities. Craig was a pleasure to work with, he did everything he said he would do and met all of our stringent deadlines. I have read through the reports and the results are quite detailed and useful and the test planning was thorough and the test results met the requirements needed for submissions to regulatory bodies. I have great confidence in both the process and the deliverables. We recently purchased the LDT-1500 linear fatigue test machine from BDC Labs. Both the machine and the level of technical support were excellent. With a shorter lead time and a price that was a fraction of the cost of competitive machines from other vendors, we remain very pleased with our purchase. BDC Labs has been a great resource to us over the past 18 months in our catheter development program. Craig and the entire team at BDC has a wealth of experience that we were able to leverage to expedite our project.
Being a small organization with limited resources, and given that our core expertise is in chemistry and surface modification technology, we were able to utilize BDC in performing a number of physical tests that otherwise would have required investment in additional equipment and personnel to complete. Test methods and reports are logical and MedicGLP.com well written. They are knowledgeable, responsive to timeline pressures, technically competent and an excellent thought partner in problem solving. We look forward to continuing to work with BDC Labs in current and future projects. InnerPulse is a small company engaged in the development of a cardiac rhythm management device implanted in the thoracic cavity. The novel design and implant location of the device meant that standard reliability testing equipment was not applicable. Custom equipment designed from scratch would be required. Working with BDC, we were able to quickly build a test fixture that simulates the thoracic cavity.
Our collaboration with BDC was productive from the start. BDC was clearly well versed in the mechanical and electrical design of custom testing equipment, the construction of mock vessels, and the human anatomy relevant to our project. BDC’s expertise with hemodynamics is a great asset to our catheter development efforts. Furthermore, their desire and ability to help troubleshoot issues ensures they are not just another contract lab that performs testing and returns reports; instead, BDC is a true partner with our R&D team. We have used BDC testing services, purchased their test equipment and their silicone mock vessels, all of which have met or exceeded our expectations, been cost effective and delivered in a very timely manner. BDC’s knowledge base surrounding the medical device development and regulatory environment is excellent. The BDC team has been responsive and very supportive of our needs allowing us to develop a very productive relationship with the team and we plan to continue to use their well-tuned services and products.