I will develop iso 13485 qms documentation, sops writing, medical device procedures

Looking to achieve ISO 13485:2016 certification or upgrade to the new 2026 FDA QMSR? As a Lead Auditor (10+ years experience), I build and audit Quality Management Systems that pass Notified Body and FDA inspections with zero friction.

Services for EU MDR, FDA, TGA & MDSAP:

• BASIC (Internal Audit & Gap Analysis): A professional ISO 13485 internal audit. You receive a detailed Gap Analysis report with corrective action recommendations to ensure audit readiness.
• STANDARD (Documentation Pack): A complete QMS documentation suite, including a custom Quality Manual, core SOPs (CAPA, Risk, Change Control), and all mandatory forms/templates.
• PREMIUM (Full QMS Implementation): End-to-end consultancy. I handle everything from gap analysis and ISO 14971 Risk Management to full drafting and certification support for MDR/FDA markets.
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Why My Service?

• Expertly Crafted: Designed by a Lead Auditor to meet MDSAP and QMSR standards.
• Audit-Ready: Structured files that reduce regulatory back-and-forth.
• Tailored: Lean systems that scale with your business.
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Lets secure your ISO 13485 certification. Please message me to discuss your device class before ordering!