Featured Projects
ISO 7FDA 21 CFR 820Medical Devices
Medtronic - Production Line Expansion
Medtronic México
Expansion of ISO 7 clean room for new medical device production line. Project executed without stopping existing production, meeting FDA requirements and good manufacturing practice standards.
Key Highlights
- Expansion without existing production interruption
- FDA 21 CFR 820 compliance
- Redundant HVAC system for operational continuity
- Complete IQ/OQ/PQ validation
- Bilingual documentation for corporate audits
Project Data
- Classification
- ISO 7
- Standard
- FDA 21 CFR 820
- Area
- 350 m²
- Duration
- 28 weeks
- Industry
- Medical Devices
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