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David Waya

I3CGlobal offers expert ISO 13485 consultants who help medical device companies establish, implement, and maintain a compliant Quality Management System. Their consulting team guides you through documentation, internal audits, process validation, and regulatory alignment based on global standards. With years of hands-on industry experience, I3CGlobal ensures your QMS enhances efficiency while meeting MDR, FDA, and international requirements. Their practical approach supports both startups and established manufacturers in achieving smooth ISO 13485 certification and long-term operational excellence.

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