Delphi Consulting Group (DCG)

 

WORLD WIDE

  

Your Source for US FDA 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, or James.Knauss@delphiconsulting.com

                     

 

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 customer’s 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!

Check out this CCS document: click here

Contact:

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

 

 

 

Delphi Consulting Group (DCG) is a consulting company specializing in medical device US Food & Drug Administration and Health Canada release to market.  Use of Internet and video conference reduces need for travel to zero, thus, reducing project costs.

Why Choose Delphi Consulting Group?

bulletDCG provides practical solutions to your regulatory problems while assisting you to meet the agency's requirements, and
 
bulletWe have received positive respond to selected US FDA and Health Canada regulatory concerns thought our over twenty years of experience working with these agencies.
 
bulletEXCLUSIVE - A published estimated of the cost of FDA Submissions for release to the US market. Click here.

Capabilities Sampler

Release to Market

Delphi Consulting Group (DCG), provides comprehensive medical device release to market.  DCG provides full turnkey submissions working as a facilitator.  Download FDA 510(k) requirements document as prepared by DCG - Click  Here.

 DCG will monitor testing laboratories and their reports for suitability to requirements.  Prepare submissions, monitor FDA review and provide counsel on any FDA request for additional information (AIs) or Refuse to Accept replies. 

DCG provides comprehensive new device review and risks analysis to investment groups.

DCG can, based on degree of known data, provide a not to exceed (NtE), cost budget for 510(k) submissions.

DCG will help you during the US 510(k), 513g, IDE, PerSub or PMA  and/or Health Canada submission process by:

bulletPerforming a 510(k), IDE, PreSub, PMA or Health Canada assessment to identify or confirm the most appropriate predicate device (s)
 
bulletPrepare and file a FDA 513g submission to secure FDA guidance on appropriate predicate device (s) if necessary
 
bulletDeveloping and preparing a written argument for "substantial equivalence" that will compare your device to the predicate devices. 
 
bulletIdentifying any applicable FDA and Health Canada Guidance Documents
 
bulletCommunicating directly with FDA or Health Canada staff to identify any special requirements that may impact the review of your 510(k), 513g, IDE, PMA or Health Canada Application if necessary
 
bulletPreparing and submitting the 510(k), 513g, IDE, PreSub, UDI labeling or PMA  documents and electronic optical disks to the FDA
 
bulletCoordinating and communications and negotiations with the FDA and or Health Canada reviewer, and preparing responses to FDA and or Health Canada  questions, if necessary
 
bulletTransfer of Client file are located in Dropbox (recommended), OneDrive, and Google cloud file storage and sharing available .  File are shared with client, can be edited on line and client may add new files to listing.  
 

NRC Listings

NRC listing and license for Medical Sealed Sources with Federal and Agreement States regulatory agencies
 

QSRs - GMPs

Prepare customized Quality System Regulatory SOPs for US FDA GMP (CFR 21 - Part 820), compliance.

Newsletter

Monthly free newsletter (Oracle) with current medical device regulatory, computer and business issues.

Software

Regulatory control software from Grand Avenue Software Company. DCG recommended.

US Agent Services

DCG provides FDA required US Agent Services for companies outside of the U.S.

MDSAP Audit Plan

DCG can provide assistance with setting up and conducing MDSAP (Medical Device Single Audit Plan). It looks like this will be a requirement in Canada, Japan, Australia, and USA soon.  Contact DCG for details on this new audit plan and how it will effect your company.

 

Send mail to  harvey.knauss@gmail.com for questions or comments about this web site.
Copyright © 2019 Delphi Consulting Group
Last modified: 07/06/2021

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