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- Identification Procedure | ISO 13485 | FDA QSR Compliant
Identification Procedure | ISO 13485 | FDA QSR Compliant
$99.00
$99.00
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The ISO 13485 Identification Procedure governs the identification and the acceptance status of finished medical devices, components, materials, in-process devices, and returned devices manufactured by the company.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
SKU:
SOP 7-007
ISO 13485 Identification ProcedureThe Identification Procedure governs the identification and the acceptance status of finished medical devices, components, materials, in-process devices, and returned devices manufactured by the company.
ISO 13485 Identification Procedure OverviewThe Identification Procedure ensures all products will be identified during all phases of manufacturing including receipt, production, distribution, and service.
ISO 13485 Identification Procedure ComplianceThe Identification Procedure is ISO 13485:2016 and FDA QSR compliant.
To learn more about our ISO 13485 Identification Procedure contact us at [email protected]
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Lot Inspection Procedure | ISO 13485 | FDA QSR Compliant
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The ISO 13485 Lot Inspection Procedure governs lot inspection and the systematic review of inspection levels applied to lot inspection.
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Nonconforming Material Procedure | ISO 13485 | FDA QSR Compliant
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The ISO 13485 Nonconforming Material Procedure establishes a process to control and disposition nonconforming material identified during receiving, in-process, or final product acceptance activity.
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Sterile Load Preparation - Release Procedure | ISO 13485 | FDA QSR Compliant
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The ISO 13485 Sterile Load Preparation and Release Procedure provides instruction preparing sterile loads, inspection of loads pre and post sterilization, and the requirements to release sterile loads for commercial distribution.
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Unique Device Identification Procedure
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The Unique Device Identification (UDI) Procedure governs the process of creating, submitting and maintaining Unique Device Identification (UDI) and BASIC UDI-DI codes for the FDA GUDID and EUDAMED database systems. The UDI procedure meets FDA / EUDAMED Issuing Agency GS1 standards and the requirements of 21 CFR Part 830 and MDR 2017/745.
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