2.5. Product Specifications
The product specifications are the formal design inputs and as such must contain the information about the product, material characteristics, packaging characteristics, required functional, performance, reliability, usability, labeling, delivery, safety, and security requirements, and any installation/servicing requirements.
Detailed technical requirements and characteristics for the individual components or parts that make up the final medical device product.
Critical quality control checkpoints to verify that raw materials, components, and initial production units meet all specified requirements before proceeding with manufacturing.
Communication of design changes, nonconformities, quality issues, and regulatory updates.
Device Master Records and Bill of Materials (BOM) Management refer to the comprehensive documentation and control of the product design specifications, components, and manufacturing information.
The proper identification, procurement, and maintenance of safety information for all materials and substances used in the manufacturing of the medical device.
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Key components of the medical device design control process, providing detailed manufacturing procedures and comprehensive production history documentation to maintain quality and traceability.
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The formal review, approval, and documentation of any changes made to the product specifications, ensuring the changes are properly evaluated and implemented to maintain product quality and compliance.