Delphi Consulting Group (DCG)

An Internet based medical device regulatory service company.

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

 

Delphi Consulting Group (DCG) is a consulting company specializing in medical device US Food & Drug Administration release to market. 

Why Choose Delphi Consulting Group?

bulletDCG provides practical solutions to your regulatory problems while assisting you to meet the agency's requirements, and
 
bulletwe respond to selected US FDA regulatory concerns thought our over twenty years of experience working with the FDA.

 

Release to Market

Delphi Consulting Group (DCG), provides comprehensive medical device release to market.  DCG provides full turnkey submissions.  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). 

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 510(k) submission process by:

bulletPerforming a 510(k) 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 devices(s) if necessary
 
bulletDeveloping and preparing a written argument for "substantial equivalence" that will compare your device to the predicate devices(s) 
 
bulletIdentifying any applicable FDA Guidance Documents
 
bulletCommunicating directly with FDA staff to identify any special requirements that may impact the review of your 510(k), if necessary
 
bulletPreparing and submitting the 510(k) documents and electronic optical disks to the FDA
 
bulletCoordinating and communications and negotiations with the FDA reviewer, and preparing responses to FDA questions, if necessary

QSRs - GMPs

Prepare customized Quality System Regulatory SOPs for 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.

 

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Last modified: 05/27/10