Delphi Consulting Group (DCGroup)

WORLD WIDE

   Medical Device Regulatory Service Company that is Internet Based

Your Source for US FDA and Canadian Medical Device Release to Market

Home of the DCG iSubmission and iDocuments

Houston, Texas USA Based, Worldwide Service

Established in the year 1988

Experience Matters.

Telephone + 832-675-9281  -6 GMT, info@delphiconsulting.com

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

 

 

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ASSOCIATE GROUPS

COOPER CONSULTING SERVICE (CCS)

Established in 1986.  Medical Device design, prototype and testing regulatory services.

Cooper Consulting Service (CCS) has a broad range of engineering capabilities.  We have designed numerous medical devices, ranging from teaching products to critical care systems.  Our services are tailored to client needs and can range from turn-key product design to supporting a specific aspect of design or test.  Working with CCS puts 100+ years of engineering experience on your team!

CCS is committed to our customerís success and has worked with companies large and small, from all over the world.  Our team wants to help you bring your product from concept to commercial success!

Contact:

www.cooperconsultingservice.com  or phone +281-482-9786

 

 

 

 

Delphi Consulting Group (DCGroup) provides U.S. Food and Drug Administration and Canadian Health 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 Zoom,  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 and Canada. With the following services; Good Manufacturing Practices [GMP], documentation, acting as US Agent, and other FDA and Health Canada 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 is a standalone firm with low overhear and works to keep your FDA and Health Canada regulatory submission costs very low.

Company Profile

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

DCG was established in the year 1987, experience is good.

DCG's client base is world wide.

Capabilities, but not limited to the following:

bulletFDA Premarket Notifications -- 513g / 510(k ) / IDE / PMA / Q Submissions (PreSub) / Electronic Submissions
 
bulletHealth Canada Medical Device Licence
 
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
 
bulletUS based Manufacturing Quality Systems (GMP) SOPs written to fit your business plan
 
bulletU.S. Agent for off-shore manufacturers
 
bulletAssist with replies to FDA Inspection 483, and Warning Letters
 

Company principals are James Harvey Knauss. For c.v. click here.

 

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Send mail to harvey@delphiconsulting.com or harvey.knauss@gmail.com for questions or comments about this web site.
Copyright © 2019 Delphi Consulting Group
Last modified: 08/14/2019

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