2.3. Environment Control (Manufacturing, Storage)
The controlled conditions, such as temperature, humidity, cleanliness, accessibility and layout, required for the production and storage of the medical device and its components to meet the specified design and quality requirements.
Systematic and controlled movement, storage, and management of materials, components, and products throughout the production process.
Specialized, highly-regulated, and tightly-controlled area or facility designed to minimize the introduction and presence of contaminants.
The storage and management of raw materials, in-process materials, and finished goods are critical components of the overall material handling and quality control processes.
Range of activities to ensure the seamless and compliant distribution of products, including managing the distribution network, optimizing inventory and order fulfillment, maintaining product traceability and recall management, and continuously monitoring and improving the distribution processes.
Critical regulatory requirement requiring device manufacturers to register their facility with regulatory bodies such as the FDA that ensures the manufacturing sites and other related facilities meet the necessary standards for the production, handling, and distribution of medical devices.
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Critical aspect of maintaining regulatory compliance and ensuring the continued quality and safety of medical devices that includes identifying and evaluating proposed changes, conducting risk assessments, implementing a formal change control procedure, validating and qualifying the modifications, training personnel, communicating with stakeholders, and continuously monitoring the changed facility or processes for ongoing compliance and improvement.
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Critical component of business continuity and risk management that includes risk assessment, data and system backup, establishing alternate manufacturing sites, and establishing a comprehensive incident response plan for when an unexpected disaster occurs that could adversely affect the business activities or device development, installation, monitoring or maintenance processes.