I will quality management system sop work instructions and capa for iso 13485

Are you looking to establish, improve, or audit your Quality Management System (QMS) or strengthen your CAPA process for medical devices or IVD products?

I am a Lead Auditor with 7+ years of experience in the medical device industry, supporting companies across IVD, SaMD, and traditional medical devices to achieve compliance with global regulatory requirements.

I provide practical, audit-ready solutions aligned with:

• ISO 13485
• EU MDR & IVDR
• US FDA (21 CFR Part 820 / QMSR)
• SFDA (Saudi FDA)
• UKCA
• TGA (Australia)

What I Can Do for You

QMS Development & Improvement

• Full QMS setup (from scratch or gap-based)
• SOPs, procedures, and quality documentation
• Audit readiness and compliance alignment
• Internal audit support

CAPA System Implementation

• CAPA process design and optimization
• Root Cause Analysis (RCA) methodologies
• Nonconformity handling (NC, deviations, complaints)
• Effectiveness checks and closure support

Regulatory & Audit Support

• Mock audits (ISO 13485, MDR, FDA)
• Gap analysis against regulations
• Technical documentation support
• Inspection readiness (SFDA, FDA, NB audits)

Why Work With Me

• Lead Auditor with real audit experience

Contact me before placing an order to discuss requirement