ISO 13485 COMPLIANT PARTNER
From Concept to Validated Sterile Release.
Providing medical device companies with technical engineering, quality oversight, and sterile supply chain management across Asian manufacturing hubs.
NPI & Engineering
Design transfer and IQ/OQ/PQ supervision per 21 CFR 820.30, ensuring lab specs are realized on the floor.
Quality Assurance
Rigorous on-site auditing and CAPA management ensuring compliance with global FDA and EU MDR standards.
Sterile Supply Chain
Specialized monitoring for ISO Class 7/8 cleanrooms and validated terminal sterilization cycles.