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Clinical Device Group Inc (abbr. "CDG") is a medical device consultancy based in Chicago, Illinois. Founded by Nancy J. Stark, Ph.D. in 1990, the business is focused on clinical and regulatory consulting for medical devices. CDG helps prepare clinical evaluations for European market entry, preparing 510(k)s and IDEs for FDA reviews, assessing the biological safety of materials and devices, and statistically analyzing existing data sets or assessing the biocompatibility of existing processes, products, or materials.
- Consulting
- Training
- Books and Productivity Tools
CDG has worked on a wide range of technologies, including:
- Orthopedic products
- Bone growth stimulation
- Wound dressings and vacuum–assisted systems
- Respiratory and oxygen–monitoring systems
- Soft tissue augmentation
- Hemostatic agents
- Interventional systems (pacemakers, leads, and stents)
- Hospital beds and equipment
- Urinary incontinence technologies
CDG was founded in 1990. Organizationally, the head office consists of the President (and owner) Dr. Stark and 2-3 support personnel. Dr. Stark personally negotiates each consulting agreement to ensure that only work for which she has personal expertise will be contracted.
Once an agreement is in place and a statement of, the implementation is outsourced to one of its many independent experts, CDG's so-called "Network Staff". The Network Staff experts are scattered all over the States and Europe. The expert with the best background for the project (i.e. technological experience) is assigned to implement the statement of work.
