Files for Download

The following files are available for download.

File Name	Description
Med_Dev_Directive-1993.exe	Here is a Microsoft Word version of the Medical Device Directive. The file can be downloaded in self extracting executable format. The Medical Device Directive has been downloaded 388 times.
510kListing.exe	This is Access 97 file containing a listing of all 510(k)s through March 8, 2004. If you are tired of staring at all capitalized letters and not being able to look at the data in tabular format when using the FDA 510(k) database, then this file is for you. If the response to this file is good I will up-date it on a monthly basis. Email me if I get lazy about this. The 510(k) listing has been downloaded 460 times.
fmea.exe	This is an MS Excel file that was given to me by Christian Lupo. He says about the file: "I have used for Design and process FMEA's for years. It calculates RPN based on S, O, and Detection. It also contains files for creating flow diagrams before you begin your FMEA and control plans when you are finished. Design and process FMEAs are only part of this file. There are many useful tools that could be used to support a submission (510K, NDA, MDD), or a companies quality system in general. Companies contract me as an independent consultant through word of mouth, and (at this time) it is not my primary occupation. Although this software was designed to support the automotive industry, I have used it when consulting with medical device, aerospace, and non-sector specific manufacturing/service. This program does not explain how to create a FMEA but it is a convenient format to record your information that is adaptable to any industry." The FMEA file has been downloaded 2255 times.
SpellMedSetup.exe	SpellMed is an add-on spell check dictionary for Microsoft Word. SpellMed contains a 29,000 word dictionary of medical terms that can be seamlessly integrated with the Microsoft Word spell check utility. Additionally, SpellMed includes a utility that will permit you to find and edit any custom dictionary used by Microsoft Word or other application that uses the Microsoft Word object model for spell checking.

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Last modified: March 15, 2008