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Newark, DE
Tempe, AZ
Tempe, AZ
Livermore, CA
The mission of BDC Laboratories is to offer products and services to the medical device industry that aid in functional evaluation of technologies as related to clinical outcomes.
Biomedical Device Consultants was formed in 1977 by Dr. Steven Weinberg as a consulting company, to provide general R&D services to the medical device industry. To meet the needs of BDC’s domestic and international clients, a GLP engineering testing laboratory was established in 1985. By combining the laboratory and consulting services within a single company, the clients of BDC Labs obtain the benefits of over 30 years of medical device development and testing experience in one company. In 2006, Dr. Craig Weinberg joined the company bringing an influx of new energy and technology to the business. In 2007, a second facility was opened in Wheat Ridge, Colorado to accommodate the expanding capabilities and business. From this foundation, along with our highly technical personnel, BDC Labs is capable of providing support in all aspects of product development and evaluation for developmental and regulatory activities.
BDC has been active in the professional community for over 30 years. Dr. Steven Weinberg was one of the founding members of the Society for Biomaterials and has long standing relationships with biomaterials experts in all aspects of blood and tissue contact biomaterials and biomaterials testing. Furthermore, the BDC team continues to be active members in multiple standard organizations including The Association for the Advancement of Medical Instrumentation (AAMI), The International Standards Organization (ISO) and The American Society for Testing and Materials (ASTM).
BDC’s sister company, Biomedical Development Laboratories offers contract product and process development support in Class II and Class III medical devices in the area of expanded PTFE (ePTFE). BDL’s capabilities include design and manufacturing of all ePTFE manufacturing equipment necessary to manufacture ePTFE based disposables and implantables. BDL is capable of supplying blending, billeting, extrusion, stretching, sintering, and printing equipment as well as all associated production and process technology.
9 Community Reviews 4.78/5 Overall Rating
Chyeh
R & D / Engineering , Medical Device
02/24/2014
The team at BDC are a great team and very engaged staff. This is incredibly important for the level of testing and quality of testing services they provide (life/fatigue testing, stent testing, heart valves, etc.). Many tests using devices such as the ones i've had subjected to their testers, are extremely unique. Their staff and their owner Craig are incredibly attentive to this and ensure that all testing performed are done with the utmost detail and attention.
Their pricing is very competitive as well considering the caliber of tests they do perform. I have no doubts of my data when discussing with their team my results and have successfully filed with the final results provided by their labs with the FDA and CE bodies.
They also have the capability to manufacture their own in-house silicone mock vessels to your specific requirements (as i have requested for in the past)
Strengths: Excellent and attentive staff. Great quality of work and thorough understanding of the testing they are doing as well as the customer requirements. Excellent pricing
Needs to improve: None
medevexec
General Administrative , Medical Device
03/25/2014
BDC helped us out of a jam with a device that could not be adequately tested elsewhere. They worked closely with our team and learned along side of us and we developed the appropriate test for this non-standard medical device.
Strengths: BDC offers products and testing services to the medical device industry that aid in the mechanical and functional testing of medical device technologies as they relate to clinical outcomes. They are very experienced in their ability to identify the best testing regime for your product, and are willing to work with your engineers closely to determine proper, not canned, parameters to suit your needs.
Needs to improve: A little costly, similar to others
My start up uses BDC lab to help us fulfill the criteria for FDA submission of our prototype medical device. They were very knowledgeable and most importantly thorough so that we were able to hit the specific validation points. Their highly specialized testing solutions were exactly what we required as their expert team knew the FDA approval process well and were up to date on all esoteric protocols. Top notch customer service as they were always accessible and happy to offer insight. Will definitely use them again.
Strengths: Industry expertise, short lead times, high quality results
Needs to improve: None
We contracted BDC lab to help us meet the criteria for FDA submission. Their customized testing solutions were exactly what we needed as their expert staff knew the industry well and were up to date on all necessary protocols. They were very professional and most importantly thorough so that we knew exactly what we were dealing with. Great customer service as they were always easy to reach and happy to offer insight. Quality results from a solid team.
Strengths: product quality, customer service, proficiency, lead time, reliability
Needs to improve: none
Used this group for customized testing that ended up in an FDA submission. Usually they deal with stents and are very up to date with current testing procedures. They were able to custom design a test that fit our needs. However, it did take quite some time, but that is expected for customized testing.
Strengths: Customized solutions
Needs to improve: Long lead times
I worked with BDC to test a device a few years ago. They are experts in testing and work very closely with you to ensure that your needs are met. Their expertise in device standards is also a very valuable resource.
Strengths: Medical device testing
Needs to improve: None
Good test lab and very knowledgeable team. Wes used BDC to perform some custom testing and they were very attentive to the specific needs of our test and managed testing and observations extremely well. Report is well written and clear.
Strengths: Fatigue testing
Needs to improve: None
a excellent test lab and knowledgeable staff. i had some custom testing performed and they were very attentive to the details around it and managed testing and observations extremely well.
Strengths: Knowledgeable staff, very attentive to details
Needs to improve: none
excellent testing lab for various medical device testing requirements. we have used them for some device testing and the staff has been exceptional in their support and knowledge
Strengths: great customer support, knowledgeable
Needs to improve: none
