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ISO 13485 Compliance for Medical Device Stamping Process
I am currently working in medical device manufacturing and would like to better understand how stamping processes can be aligned with ISO 13485 requirements. Specifically, I am looking for guidance on:
1. Process validation requirements for stamping operations
2. Documentation needed (SOPs, work instructions, records)
3. Traceability and quality control measures
4. Risk management considerations during stamping
I have come across industry practices from companies like Akstamping, and I am trying to understand how such processes are aligned with ISO 13485 in real-world scenarios. If anyone has practical experience or examples of implementing ISO 13485 in medical device stamping processes, your insights would be very helpful.