ISO 13485 QMS Implementation
Achieve ISO 13485:2016 certification with a quality system built for your manufacturing reality.
The Challenge
Common pain points that prevent medical device manufacturers from achieving sustainable compliance.
Complex Standard Requirements
Navigating ISO 13485 requirements while maintaining production efficiency feels overwhelming.
Documentation Overload
Creating compliant documentation that staff actually use, not just shelf-ware.
Audit Anxiety
Uncertainty about whether your QMS will pass Notified Body audits on first attempt.
The VigilaMed Solution
ISO 13485:2016 Certification Pathway
We design and implement ISO 13485:2016 compliant quality systems that integrate seamlessly with your manufacturing operations. Our approach ensures first-time certification success.
Manufacturing-First Methodology: We build your QMS from the ground up, ensuring every procedure is practical, implementable, and audit-ready. No templates—only custom solutions.
What You Get
Tangible deliverables that deliver immediate value and long-term compliance.
- ISO 13485:2016 Quality Manual
- Complete SOP Library (25+ procedures)
- Risk Management System (ISO 14971)
- Management Review Framework
- Internal Audit Program & Schedule
- Certification Readiness Assessment