2.4. Manufacturing Processes
The documented procedures, equipment, and methods used to produce the medical device in a consistent and controlled manner, ensuring the final product meets the design specifications and regulatory requirements.
Crucial tool for medical device companies to understand, document, and optimize their production workflows and procedures.
Process Failure Mode and Effects Analysis is a critical tool to identify and mitigate potential failures within the manufacturing processes.
Process to ensure the reliability, accuracy, and consistency of the testing procedures used to evaluate the performance, safety, and quality of medical devices.
Installation Qualification, Operational Qualification, and Performance Qualification ensure that manufacturing equipment and instrumentation are properly installed, operated, and performing as intended.
Plan that maps out the essential components of a medical device company's QMS, ensuring the reliability and consistency of their manufacturing processes.
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Ensuring that manufacturing processes consistently yield products meeting predetermined quality criteria.
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Defining, monitoring and managing KPIs to ensure consistent product quality and compliance with regulatory standards.
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Systematic checks during production and after completion to verify that the products meet specified quality and safety standards.
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Critical procedures that ensure products are safe, effective and free from contaminants, requiring rigorous validation due to their impact on product quality and patient safety.
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Maintaining detailed and accurate documentation of production activities, ensuring traceability, compliance with regulatory requirements, and the ability to review and verify the manufacturing process and product quality.
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Continuously tracking and analyzing production parameters and performance metrics to ensure processes remain within specified limits.
Process Change Management
Systematically evaluating, approving and documenting any changes to production processes, to ensure that these changes do not adversely affect product quality or safety.
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Implementing and maintaining systems and procedures to ensure that all services related to the product lifecycle consistently meet quality and regulatory standards.
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Identification, design, and implementation of automated processes and systems to improve the efficiency, consistency, and reliability of manufacturing operations.
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Used to systematically monitor, evaluate, and optimize manufacturing processes through the collection and statistical analysis of process data, enabling proactive identification and resolution of potential issues to ensure consistent product quality.