ISO 13485 CERTIFICATION IN KUWAIT

ISO 13485 Certification in Kuwait

ISO 13485 Certification in Kuwait

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ISO 13485:2016, specifically Clause 7.5.9, ISO 13485 Certification cost in Kuwait requires medical device manufacturers to establish and maintain a documented system for product identification and traceability. This system must ensure that the identity of the product is preserved from receipt of raw materials through manufacturing, distribution, and, when required, post-market activities.

1. Product Identification


At every stage of the product life cycle, items must be identified by:

  • Product name or code


  • Batch or lot number


  • Serial number (for individually tracked devices)


  • Manufacturing date or expiry date (as applicable)



Identification ensures that each component, subassembly, and finished product can be clearly distinguished and traced.

2. Traceability System Components


A comprehensive traceability system typically includes:

  • Bill of Materials (BOM): Links every component and raw material to the final product.


  • Lot and Serial Number Tracking: Allows the tracking of individual batches or units.ISO 13485 Certification services in Kuwait


  • Device History Records (DHR): Maintains detailed records for each manufactured lot or serial number, including:



    • Production steps


    • Inspection and test results


    • Personnel involved


    • Equipment used




  • Supplier Traceability: Ensures that critical raw materials or components are linked to suppliers via purchase orders, incoming inspection records, and supplier batch numbers.


  • Distribution Records: Tracks where each product was shipped, enabling rapid identification in case of recalls or complaints.



3. Software and Digital Systems


Many organizations use Enterprise Resource Planning (ERP) or Manufacturing Execution Systems (MES) integrated with barcode or RFID systems to automate traceability. These systems capture real-time data, reduce human error, and enhance visibility across the supply chain.

4. Risk-Based Approach


ISO 13485 requires that traceability be maintained in proportion to the risk associated with the product. For implantable or high-risk devices,ISO 13485 Certification process in Kuwait more stringent traceability (e.g., down to individual units) is mandatory. This may also include:

  • Linking the device to the patient


  • Recording the implanting healthcare professional or institution


  • Keeping data for a defined retention period (e.g., 15 years post-distribution)



5. Control of Records and Documentation


Traceability records must be:

  • Maintained and protected to prevent loss or unauthorized changes


  • Retained for a period defined by regulatory and organizational requirements


  • Accessible for audits, recalls, or regulatory inspections



A robust traceability system not only fulfills ISO 13485 Implementation in Kuwait requirements but also supports regulatory compliance (e.g., FDA, EU MDR), enables efficient field actions, and ultimately helps ensure patient safety and product integrity.

 

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