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.

 

 

 

 
Quality System Regulations (QSR)

Good Manufacturing Practices (GMP)

Standard Operation Procedures (SOP)

  •   QSR (GMP) Writing -- Prepare customized Quality System Regulatory SOPs for FDA GMP compliance.  The SOPs can be paper or computer media based.  DCG SOPs have been audited a number of times by the FDA and always been accepted. 
     
  •   QSR SOPs are provided in printed copy, word processor files of choice, and Adobe Acrobat pdf.  All files are provided on CD-W disks.  Copyright of custom SOPs are transferred to client.
     
  •   File choices are:  Microsoft Word [Word 2000-97 and Word 2007 (.doc)], Corel WordPerfect, SunOffice 6.0 under Microsoft Windows operating systems.  SunOffice under Linux operating system.
     

QSR SOPs Information Request Form

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Copyright © 2007 Delphi Consulting Group
Last modified: 06/10/08