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CDG's Biological Safety Rescue Squad
Medical Device Biological Safety For example, FDA raised the question if an implanted material might have a local oxidative effect. The question required the design of a unique animal test and a focused literature search reviewing the chemistry of the materials. In another example, FDA wanted to know the concentration of unreacted monomers, bimers, and trimers to the ppb level in a plastic, the analytical testing required a unique design. In a third example, reviewers wanted to know the possibility of an implanted material injuring a nerve, the solution required a sub-chronic test in which devices were implanted in dogs. Clinical Device Group’s Rescue Squad Your first contact with Clinical Device Group will be with Nancy J Stark, PhD. With a doctorate in biochemistry, Dr. Stark will assess your biological safety questions and determine if the firm is able to help you. She will answer your initial questions about the company, its history, services, and rates; will sign a confidentiality agreement and negotiate a service agreement with you. Once the administrative end of the relationship is in place, you’ll be referred to our primary toxicologist, Dr. Daniel McLain.
Dr. McLain is an internationally recognized toxicologist in the medical device industry and currently serves as the Convener for ISO 10993: Biological evaluation of medical devices – Part 11: Systemic toxicity evaluation. It is an extreme honor to serve as a convener, because it is a nomination of your peers, recognizing your expertise in the technical area and ability to work with people to bring them to consensus. He has had extensive interaction with global regulatory bodies as it pertains to product safety submissions and is held in high regard for his development strategies and commitment to product safety. Now for Some Fun
Second, take Poll du jour 6, a 30-second quiz about FDA's views on biological safety and see how your answers compare to others.
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