QMS Development
Build a Quality System that accelerates production, not slows it down.
The Challenge
Common pain points that prevent medical device manufacturers from achieving sustainable compliance.
Bottlenecked Production
Over-complicated SOPs that staff ignore, causing workflow delays and compliance gaps.
Legacy Paperwork
Paper-based systems causing data gaps, lost documents, and audit preparation nightmares.
Reactive Preparation
Scrambling before audits instead of maintaining continuous compliance readiness.
The VigilaMed Solution
Manufacturing-First QMS Implementation
We implement lean, audit-ready systems tailored to your specific device class. Our methodology prioritizes operational efficiency while ensuring full regulatory compliance.
Manufacturing-First Methodology: Our Manufacturing-First approach means your QMS integrates seamlessly with production workflows. No more compliance vs. efficiency trade-offs.
What You Get
Tangible deliverables that deliver immediate value and long-term compliance.
- Quality Manual (ISO 13485:2016 compliant)
- SOP Core Pack (20+ procedures)
- Risk Management File (ISO 14971)
- Documentation Control System
- Training Materials & Implementation Plan