Company:Clinical Device Group
| File:ClinicalDeviceGroupLogo.jpg | |
| Type | Corporation |
|---|---|
| Industry | Medical Device |
| Founded | 1990 |
| Headquarters | Chicago , Illinois, United States |
Key people | Nancy J. Stark, President |
| Website | www.clinicaldevice.com |
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 has consulting expertise in preparing 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.[1]
Services
- Consulting
- Training
- Books and Productivity Tools
Projects
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
Organization and History
CDG is a small corporation with a long history. It was founded in 1990, before medical device companies even knew they needed regulatory consulting. It is believed to be the oldest clinical and regulatory consulting for the medical device industry in the States.
CDG deliberately chose to remain small, privately held company, corporation in order to ensure the quality of the consulting work-product. 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.[2]
References
- ↑ Stark, Nancy J.. "Clinical Device Group: A Medical Device Consultancy and CRO". http://www.clinicaldevice.com/Services.htm. Retrieved 2014-08-20.
- ↑ Stark, Nancy J.. "Clinical Device Group: A Medical Device Consultancy Brochure".
A collection of Dr. Stark's whitepapers, articles, and books can be found on her blog and website.
External links
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