Medical Device Regulatory Services

Delphi Consulting Group (DCG)

An Internet based medical device regulatory service

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Regulatory Assistance with medical devices and the US FDA.

 

 

 

Our Mission

Delphi Consulting Group's mission is to make our clients regulatory needs as simple as possible and retain complete compliance with all required regulations.   DCG maximize the use of the Internet to reduce cost for client.

DCG works to provide fixed price or not to exceed cost budgets for projects.

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

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

Company Profile

Delphi Consulting (DCG) is a consulting company specializing in medical device US Food and Drug Administration release to market.  DCG was established in 1987.

We can span the bridge between your regulatory needs and regulatory agencies. 

Our Client base is world wide.

Services include but not limited to the following:

  •  FDA Premarket Notification -  510(k)/IDE/PMA
     
  •   NRC listing and license for Sealed Sources both with Federal and Agreement States regulatory agencies.
     
  •  Validations sterilization/shelf life/biocompatibility
     
  •  FDA Quality System (GMP) SOPs
     
  •  Product Operators and Service Manuals
     
  •  US Agent for off shore manufacturers
     
  •  Electronic Medical Devices Submissions
     
  •    Company principal is James Harvey Knauss.  For c.v. click here.

Contact Information

Delphi Consulting Group (DCG) is very accessible.  Telephone questions always welcome.

Office hours are:  8:30 A to 5 P, -6 GMT, Monday through Thursday.

( Telephone
+713-723-4080  Direct
+832-692-5364  Mobile
          Skype -- Harvey_Knauss
                                                   
6 FAX
+832-615-3550
     
+ Postal address
Delphi Consulting Group
11874 South Evelyn Circle
          Houston, Texas 77071-3404 USA
 
: Electronic
E-mail  hknauss@sbcglobal.net or harvey.knauss@gmail.com
          Skype IM  --  harvey_knauss         
General Information: info@delphiconsulting.com
Webmaster: harvey@delphiconsulting.com

Houston

                                                                                                                                

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Send mail to harvey@delphiconsulting.com with questions or comments about this web site.
Copyright © 2007 Delphi Consulting Group
Last modified: 06/10/08