Medical Device Regulatory Services
Delphi Consulting Group (DCG)
Contact DCG for a reduction in your regulatory cost.
An Internet based medical device regulatory service
|
Medical Device Regulatory Services Delphi Consulting Group (DCG) Contact DCG for a reduction in your regulatory cost. An Internet based medical device regulatory service
|
|
Regulatory Assistance with medical devices and the US FDA.
|
Spectrum Requirements for Advanced Medical Technologies Click here. 21 CFR Part 820 in 8 1/2 by 11 inch format. Click here. Deciding When to Submit a 510(k) For A Change To An Existing Wireless Telemetry Medical Device; Final Guidance for FDA Reviewers and Industry. Click here. FDA 510(k) Guidance on submission format. Click here. FDA User Fees for FY2010 Click here. White Paper Automatic Identification of Medical Devices, August 2005. Click here. FDA sponsored development of Unique Device Identifier. Click here. Why 90% of Medical Devices Fail Product Certification Testing the First Time Click here. We thank Intertek ETL SEMKO for this. FDA Software Guidance for Medical Devices Click here. Software Validation Guidance for Medical Devices Click here. Check back often as these documents will be up-dated when new documents of interest become available. * If you desire a copy of a document phone or e-mail Delphi Consulting Group. See Home Page for contact information. Delphi Consulting Group recommended productive software. Some of it open, all of it low cost and very productive. PIM -- Chaos Software Intellect Chaos Software Office Suite that produces Microsoft files -- e-Press One
|
|
Send mail to harvey.knauss@gmail.com with
questions or comments about this web site.
|
The following are files that contain useful regulatory information and/or
the
regulations themselves. All files are in Adobe Acrobat PDF format that
will open in Acrobat Reader. Some have Bookmarks that will
allow you to move around in the document. To view or download click
on the "Click here" words. 