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Site updated 12-Jun-09

This site brings unfettered access to relevant information about medical device development.

My 30+ years of experience (resume) incorporate state-of-the-art methods which are described here with a technical solutions page & a guidance page for regulatory compliance (21CFR-820, ISO13485, etc) with six-sigma & lean process improvement techniques.

Don Shave
President &
CEO,
Creative Logic Software, LLC 


Commercial pop-up's are irritating but not controllable--please accept my apologies?
I
f you don't use Google's toolbar , let me suggest one that worked for me: StopZilla


View Don's Bio

As an experienced engineering professional, I have developed numerous product-specific systems and software applications, along with many leadership & management roles in varied functional areas, all of which include auditable compliance with the relevant regulatory requirements.

My primary software expertise is data-mining of networked, local or paper data, producing complex analyses & reports of the data (view a recent example with an extract of the requirements spec.), as well as extensive knowledge of computer security problems with appropriate solutions.

With a talent for analyzing problems, developing & simplifying procedures, and for finding innovative, technology-based solutions, I have a proven ability to motivate & work effectively, both cross-functionally and with persons from other cultures. I'm also skilled at driving successes with limited resources in globally matrixed environments.

Key Skills
Software: C & C++, VB++ & VBA, Java, Eclipse with ANT, Windows scripting, SQL, Excel-based applications and others

Compliance: 21CFR, ISO13485

Office Tools: Microsoft Office (Excel, Word, PPT, Access...), FrontPage & HTML, eMail (OutLook, Express, gMail, HoTMaiL...) and others

GE-specific Business Tools: eNPI/PRD, eLibrary, mainframe, Oracle/cube, PROMIS/APF & others

My primary objective is to describe my consulting services and to provide some advice from the many areas I've been lucky enough to encounter.

Please eMail me (link above) with your requests, website thoughts, comments or issues? Thanks!

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The Technical Solutions page offers help, advice & suggestions for your PC challenges, along with some simple suggestions for developing applications.

A visit to the "Back Office" may provide a little backround & historical information

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Visit the Compliance page to glean some useful QMS background data for 21CFR, ISO13485 and others, as well as for some Six-Sigma guidance

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Register.com is the host behind this site; click the link to learn more about how this all works

 

 

 

 

 

 

 

 

 

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