Medical Device Manufacturing

Safeguard lives with compliant, traceable, and high-quality production. Ensure every device meets FDA and ISO standards with digital-first manufacturing execution.

Industry Challenges:

• FDA 21 CFR Part 11 compliance requirements
• Stringent validation and process documentation
• Lot and serial traceability for every device
• Rapid adaptation to regulatory changes

How Micraft MES Helps:

• Electronic records with audit trails and electronic signatures
• Process validation and control plan enforcement
• Digital SOPs and operator skill matrix management
• Batch and device-level traceability for rapid recalls

Impact Metrics: