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Delphi Consulting Group (DCG) An Internet based medical device regulatory service company.
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Regulatory Assistance with medical devices and the U.S. FDA.
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Delphi Consulting Group (DCG) provides U.S. Food and Drug Administration release to market for medical devices. DCG was formed in 1987. Please take a few minutes and review the regulatory services we provide. DCG maximizes the Internet to provide fast response, reduce travel and provide reasonable costs. With the simplest of tools, such as Skype, Skype video, Logitech VID, and / or teleconferences with share computer screens software the cost of travel can be reduced to zero.
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| FDA Premarket Notifications -- 510(k ) / IDE / PMA | |
| Provide counsel to investment groups regarding
regulatory needs and / or risks of a new or modified medical device(s) | |
| NRC listing and license for Sealed Sources with Federal
and Agreement States regulatory agencies | |
| Validations -- sterilization / shelf
life / biocompatibility / software assist with testing vendor selection and
monitor reports | |
| Manufacturing Quality Systems (GMP) SOPs written to
fit your business plan | |
| U.S. Agent for off-shore manufacturers |
Company principal is James Harvey Knauss. For c.v. click here.
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Send mail to
harvey@delphiconsulting.com with
questions or comments about this web site.
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