FDA, Good Manufacturing Practices GMP, quality system, QSR, ISO 13485, regulatory consultants, manufacturing development device, drug, diagnostic, combination medical products, 510k, PMA, IDE
Example Documents


Product Risk Profile Article and Figures
Title Catalog ID Price Desc
Product Risk Profiles Article (.pdf file -124KB ) $0.00 These articles have been written to share our experience with implementation of risk management systems in Pharma/Biotech industries. They provide detailed examples of how to create and/or perform the various risk assessment activities in a Pharma/Biotech environment. They are also written to provoke questions, points of clarification and frustrations from the industry, as this series of articles precedes a Pharma/Biotech version of our Risk Management Basics book. As a result, we ask for your comments at carol@thetamarackgroup.net. We intend to expand the examples as we have time. Let us know what would be most useful to you. Contact us to order


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Furthermore, Tamarack Associates, LLC does not warrant the accuracy or completeness of the materials at this site, and may make changes to the materials and prices at any time without notice. The information provided in these documents is of a general nature. The examples provided in the books and the example documents are simply examples for you to use as a starting template; they are not intended to address the specific circumstances of any particular organization or individual. Therefore, you should always consult a suitably qualified professional before applying the information in these documents to your specific situation.