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ISO 13485 & QMS Documentation Specialist
Freelance
Jan 2022 - Present • 4 yrs 4 mos
I specialize in preparing ISO 13485 documentation and Quality Management System (QMS) for medical device companies. I have successfully helped clients achieve ISO certification by developing audit-ready documents, SOPs, manuals, and procedures that meet regulatory requirements. My expertise includes audit preparation, compliance support, and improving existing documentation to ensure full ISO 13485 compliance. I focus on accuracy, fast delivery, and helping businesses pass certification audits smoothly.