End-to-End Quality Services
SGO Medical operates a fully equipped quality laboratory staffed by experienced quality engineers and technicians. Our testing capabilities span the complete product lifecycle from incoming material inspection through final product release, ensuring every device meets stringent regulatory requirements and customer specifications.
Testing Capabilities
- Biocompatibility Testing: ISO 10993 compliant cytotoxicity, sensitization, irritation, and systemic toxicity testing
- Mechanical Testing: Tensile, compression, fatigue, torsion, and hardness testing per ASTM and ISO standards
- Dimensional Inspection: CMM measurement, optical comparator, surface profilometry, and CT scanning
- Sterility Validation: EO and gamma sterilization validation including half-cycle and overkill methods
- Environmental Testing: Accelerated aging, temperature cycling, humidity exposure, and package integrity testing
- Cleanliness Testing: Particulate matter analysis per ISO 19227 and endotoxin testing per ISO 11737
Regulatory Documentation
Our quality team prepares comprehensive documentation packages including Design History Files (DHF), Device Master Records (DMR), risk management files per ISO 14971, and essential requirements checklists for CE marking and FDA submissions.