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   BioSculpture Technology, Inc. developed and implemented a Quality Management System to demonstrate its ability to provide consistently product that meets customer and applicable regulatory requirements, and to address customer satisfaction through the effective application of the system, including continual improvement and the prevention of nonconformity.  Our procedural guidelines are available for review and our forms provided for http or ftp protocol download.   

    The quality system complies with current good manufacturing practice (CGMP) requirements as are set forth in 21 CFR 820 so that methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing ensure that all finished devices intended for human use are safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act. The system also complies with the international standard ISO 9001 (2000) and ISO 13485 (2003).

   The manual is divided into seven sections.  The first three sections (§ 1-3) address the “particular requirements for the manufacture of medical devices” and are modeled on ISO 13485 (2003) requirements.  The next four sections  (§ 5-8) are modeled on the sectional organization of the more general ISO 9001 (2000) standard.  Sections are further subdivided into several subsections representing main quality system elements or activities. Each subsection starts with a general policy statement expressing the commitment to implement the basic principles of the pertinent quality system element or activity. The general policy statement is followed by more specific procedural policies outlining how the general policy is implemented, and referencing applicable operational procedures.           

   Another purpose of this manual is to present the quality system to our customers and other external interested parties, and to inform them what specific controls are implemented at BioSculpture Technology, Inc. to assure quality.


Robert L. Cucin, M.D.    

 Chief Executive Officer