ISO 13485 requires careful documentation from design to production. Accurate records ensure accountability, traceability, and compliance. Consultants help companies set up clear, easy-to-manage systems. Organized documents save time during audits, prevent errors, and make staff training simpler. Proper documentation also helps when investigating mistakes or product issues. Digital systems can make document management faster and more secure. Clear, accessible records improve communication across departments and ensure everyone works from the same standards.

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