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SALT COLLEGE OF APPLIED ARTS AND TECHNOLOGY SALT STE. MARIE, ONTARIOCOURSE OUTLINE COURSE TITLE:Design 1CODE NO. ADV 125PROGRAM:Graphic Designator:Terry Hillsdale:May 12APPROVED:SEMESTER:PREVIOUS
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Design History 1 code is a regulatory requirement for companies to document and maintain a history of design and development activities for their products.
Manufacturers and designers who are developing regulated products, such as medical devices, are required to file a design history 1 code.
To fill out design history 1 code, gather all relevant design documentation, including design inputs, outputs, verification, validation activities, and summaries of design changes, then complete the form following regulatory guidelines.
The purpose of design history 1 code is to ensure that there is a comprehensive record of the design process, which can demonstrate compliance with regulatory standards and facilitate product safety and effectiveness.
The information that must be reported includes design specifications, design validation results, risk assessments, change control records, and any other relevant design-related documentation.
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