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With a particular emphasis on significant risk (Class III) devices, innovative products and compliance issues, the Medical Devices Service Area delivers strategic services that help to assure appropriate reimbursement or gain product approval. We are experienced in all aspects of regulatory negotiation and submission in all medical fields. The breadth of our product experience includes many types of implants, contraceptives, endocrine modulating products, surgical devices, imaging devices, wound care products, and in vitro diagnostic devices, while our Combination Product focus utilizes the device, drug and biologics expertise in the firm. The knowledgeable professionals on our staff have advanced degrees in pharmacology, toxicology, bioengineering, epidemiology, law and chemistry, and we draw on a large network of subject matter experts to address specialized science/technology/medical issues.

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