Delphi Consulting Group (DCG)

Medical Device regulatory service company that is Internet Based

Your Source for US FDA Release to Market

Houston, Texas USA Based, Worldwide service

Telephone + 832-675-9281  -6 GMT

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Regulatory Assistance with medical devices and the U.S. FDA.

 

Delphi Consulting Group (DCG) provides U.S. Food and Drug Administration release to market for medical device companies. 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,  and / or other teleconference systems the cost of travel can be reduced to zero.

DCG is a boutique US FDA regulatory assistance firm serving worldwide medical device manufactures with product release to market in the US, Good Manufacturing Practices [GMP], documentation, acting as US Agent, and other FDA interface requirements. Our small size and low overhead costs allow us to provide prompt response to needs, with equitable overall costs.  DCG's client base is worldwide. 

 

Our Mission

Delphi Consulting Group's mission is to make our clients regulatory needs as simple and transparent as possible.

 DCG always works to ensure complete compliance with all required regulations and laws. 

DCG works to provide billing hours at a fixed price or Not to Exceed (NtE), cost budgets for some projects.

DCG always works to ensure regulatory compliance and seeks only those clients that share the same end results.

DCG operates under Regulatory Affairs Professional Society's Code of Ethics.

DCG works to span the bridge between your regulatory needs and all applicable regulatory requirements.

DCG works to keep your FDA regulatory submission costs very low.

Company Profile

Delphi Consulting (DCG) is a consulting company specializing in U.S. Food and Drug Administration medical device release to market.

DCG was established in the year 1987.

DCG's client base is world wide.

Services include but not limited to the following:

bulletFDA Premarket Notifications -- 513g / 510(k ) / IDE / PMA / PreSub / Electronic Submissions
 
bulletProvide  private counsel to investment groups regarding regulatory needs and / or risks of a new or modified medical device's
 
bulletNRC listing and license for Sealed Sources with Federal and Agreement States regulatory agencies
 
bulletValidations -- sterilization / shelf life / biocompatibility / software assist with testing vendor selection and monitor reports
 
bulletManufacturing Quality Systems (GMP) SOPs written to fit your business plan
 
bulletU.S. Agent for off-shore manufacturers
 
bulletAssist with replies to Inspection 483, and Warning Letters
 

Company principal is James Harvey Knauss. For c.v. click here.

DCG Supports and utilizes open software such as Apache OpenOffice 4, TextMaker, Chaos Intellect 4 (a CMR w/e-mail client), Linux OS,  Linux Server OS Apache and other low cost or free open software.

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Send mail to harvey.knauss@gmail.com for questions or comments about this web site.
Copyright 2014 Delphi Consulting Group
Last modified: 12/12/2014

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