Delphi Consulting Group (DCGroup)



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,

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



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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:  or phone +281-482-9786




The contents of this web site contains information that is useful to companies that wish to make a medical device submission to the FDA within reasonable costs.

Medical Device Regulatory Service Company that is Internet Based

bulletOracle Aug 19.pdf
bulletOracle July 19 B.pdf
bulletBilling rates Oct 2018.pdf
bulletcv Aug 2013 w page numbers.pdf
bulletDCG News Page
bulletFDA 510k process Jan 2014.pdf
bulletNov 2015 Oracle.pdf
bulletDCG Service 1
bulletFee Schedule10 09.pdf
bulletQSRs - GMPs
bulletDCG Service 3
bulletDCG Service 4
bulletDCG Service 5
bulletReg Information
bulletFDA_Guidance_Human Factors and Usability for Medical Devices.pdf
bulletFDA_Guidance_List of Highest Priority Devices for Human Factors Review.pdf
bulletPredicate for 510k submissions DuVal 4 2016.pdf
bulletMatrix Driver.pdf
bulletPostmarket surveillance 5 16.pdf
bulletUS FDA Issues Technical Guidance.pdf
bulletPatient information devices 6 2016.pdf
bulletFDA Issues Final Ruling Allowing.pdf
bulletFDA Finalizes Guidance on Extrapolating.pdf
bulletWhen to submit a 510k for a change 8 2016.pdf
bulletSoftware when to submit a 510k for change.pdf
bulletGeneral exceptions from the requirement.pdf
bulletBenefit risk determinations in premarket review 1818.pdf
bulletThird Party Review 9 2016.pdf
bullet2016-2017 Priorities -FINAL-1-21-16.pdf - Adobe Acrobat Pro-1.pdf
bulletMDR reporting 11 2016.pdf
bullet0045 IDE - IRB Risk Analysis 01 2017.pdf
bullet513g guidance Oct 2017.pdf
bullet0101 iDocument UDI update Nov 2018.pdf
bullet0133 iDoc Q submissions May 2019.pdf
bulletPreparing_EU_CE_TechFile_whitepaper_emergo (1).pdf
bullet0150 iDoc The EUs Medical Device Regulation.pdf
bulletInfo Requests
bulletContact Us
bulletWeb and Email Privacy Policy.pdf
bulletDCG Feedback Page
bulletDCG Table of Contents Page
bulletDCG Search Page
bulletComing Soon -
bulletweb updae 2016/Sec 8014 Meaning of intended.doc
bulletMuy Pronto - @DOMAIN@
bulletDCG Products Page
bulletAccess Denied
bulletMedical Device Regulatory Service Company that is Internet Based
bulletFile Not Found
bulletWill Criticality-Based Validation be enough for FDA
bulletDCG Product 1
bulletDCG Services Page
bulletGeneral exceptions from the requirement.doc
bulletQSR page


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Last modified: 08/14/2019

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