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Strategic Planning for U.S. Product Introductions
About Strategic Planning for U.S. Product Introductions
We can provide FDA regulatory submissions (IDE, 510k, PMAs), FDA communications and technical writing. They also have experience in clinical project management, study design, protocol development, monitoring, data management, statistical analysis and clinical reports for pre- or post-market studies, including foreign clinical studies. Training in medical device regulations, clinical trials/GCPs, quality systems/GMPs is also available.
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OrthopaedicLIST.com is a list of products and services. Every effort is made to keep this listing as accurate and current as possible. Companies and individuals are encouraged to notify us of errors and omissions. We will respond to such messages of correction in a timely fashion, as our workload permits.
We are non-judgmental of products listed. We are not in the business of evaluating products. We have not evaluated these products. We make no representations as to the quality, effectiveness, suitability or appropriateness of any of the products listed.
As an important component of the service function of OrthopaedicLIST.com, some products continue to be listed that are no longer manufactured and may not be available. We will identify them as such when possible. This allows users to find special instruments and/or components for removal, modification, and/or revision of those products.
OrthopaedicLIST.com is a list of products and services. Every effort is made to keep this listing as accurate and current as possible. Companies and individuals are encouraged to notify us of errors and omissions. We will respond to such messages of correction in a timely fashion, as our workload permits.
We are non-judgmental of products listed. We are not in the business of evaluating products. We have not evaluated these products. We make no representations as to the quality, effectiveness, suitability or appropriateness of any of the products listed.
As an important component of the service function of OrthopaedicLIST.com, some products continue to be listed that are no longer manufactured and may not be available. We will identify them as such when possible. This allows users to find special instruments and/or components for removal, modification, and/or revision of those products.