A modern ERP system helps medical device manufacturers ensure compliance by providing:
Traceability throughout the supply chain using serial number tracking and date and time stamps to track both manufactured and bought-in parts.
Traceability
Traceability helps you ensure compliance, quickly identify product recalls, and gain visibility into materials used. But relying on paper or spreadsheets makes traceability a manual,
time-consuming, and error-prone task.
Technology-enabled traceability ensures that quality goods are both compliant and delivered to happy customers. It makes sure everything can be traced back to who did it, when, and why. In the event of a product recall, traceability helps you identify affected products to minimise recall costs and identify defects prior to customer delivery.
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...into inventory from manufacturing or purchasing:
• Information captured for each serial number aids in specifying products for recall and helps identify defect sources
• Define the parameters used for serial number generation
• Generate serial numbers at the component level to connect parent and child assemblies for tracking
Traceability means being able to trace a medical device from production through its full life cycle. In order to meet regulatory demands—including Regulation 2017/745 of the European Parliament—manufacturers must have provisions in place for transparency and traceability of medical devices.
New EU medical device regulations state that all medical devices must have a Unique Device Identification (UDI) to help track and identify medical devices through their life—across manufacturing, distribution, and use.
Medical Device Traceability Ensures Patient Safety
Traceability means being able to trace a medical device from production through its full life cycle. In order to meet regulatory demands manufacturers must have provisions in place for transparency and traceability of
medical devices.
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Complete product history and visibility—from engineering, to submission, production, fulfilment, and delivery, as well as service and finance.
Product History
Inventory Management to track lot numbers for incoming raw materials through all stages of production and shipment to a customer.
Inventory Management
Store number and date information tracked at the lot level for display on specific reports, labels and search programs.
Lot Attributes
Change control and revision, controlling who has access to electronic documents, monitoring and tracking changes, recording when changes are made and who is making them.
Document Management
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...into inventory from manufacturing or purchasing:
• Information captured for each serial number aids in specifying products for recall and helps identify defect sources
• Define the parameters used for serial number generation
• Generate serial numbers at the component level to connect parent and child assemblies for tracking
Traceability means being able to trace a medical device from production through its full life cycle. In order to meet regulatory demands—including Regulation 2017/745 of the European Parliament—manufacturers must have provisions in place for transparency and traceability of medical devices.
New EU medical device regulations state that all medical devices must have a Unique Device Identification (UDI) to help track and identify medical devices through their life—across manufacturing, distribution, and use.
