Delphi Consulting Group (DCG)

An Internet based medical device regulatory service company.

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

DCG offers the following documents that contain useful regulatory information and/or the regulations themselves.  All files are in PDF format that will open in any PDF reader.

Some document files have Bookmarks that will allow you to move around in the document with ease. 

To view or download click on the "Click Here" words.

1.  21 CFR Part 820 in 8 1/2 by 11 inch format.  Click Here

2.  FDA User Fee schedule through 2012.  Click Here

3.  FDA 510(k) Guidance on submission format. Click Here

4. Software Guidance for medical devices. Click Here

5. Software Validation -  a major subject in new submissions.  Guidance Click Here PP File Click Here

6.  Deciding when to submit a 510(k) for a change to an existing wireless telemetry medical device. FDA Guidance. Click Here.

7.  Why 90% of medical devices fail product safety testing during the first test runs.  Click Here. We thank ETL SEMKO for this.

8.  FY 2010 Medical Device User Fee - Small Business Qualification and Certification.  Click Here.

Check back often as this list of documents will be up-dated when new documents of interest become available.

DCG supports Open and/or free office productive software.  Listed below are some of the programs that DCG supports.  Some are free others at low cost.

E-mail and integrated PIM management suite -- Chaos Software's Intellect program.  .

Office Suite that will produce Microsoft files --  OpenOffice3 

Send mail to harvey@delphiconsulting.com with questions or comments about this web site.
Copyright © 2010 Delphi Consulting Group
Last modified: 05/27/10