HOW IT'S MADE
From raw material to your ward.
Every TOTOMED product follows a rigorous six-stage manufacturing process — designed for reliability, traceability, and clinical safety.
Raw Material Sourcing
We source medical-grade PVC, silicone, and polypropylene exclusively from certified suppliers. Every batch is tested for biocompatibility and compliance with ISO 10993 before entering production. Only DEHP-free and odor-free grades are accepted.
Molding & Assembly
Our clean-room production lines use automated injection molding and precision tooling to manufacture respiratory masks, catheters, and circuit components. Assembly is performed under controlled humidity and particulate conditions to meet ISO Class 8 standards.
Quality Inspection
Every product batch undergoes dimensional verification, flow-rate testing, and visual inspection by our QC team. We operate under ISO 13485:2016 Medical Device QMS with full traceability from raw material to finished good.
Sterilization & Packaging
Applicable products are sterilized using validated EO (ethylene oxide) or gamma irradiation processes. Primary and secondary packaging is printed with lot numbers and expiry dates compliant with CDSCO and EU MDR labeling requirements.
Dispatch & Cold Chain
Temperature-sensitive products ship in validated cool-chain packaging. Our logistics network covers all 28 states and 8 UTs. Standard delivery within 5–7 working days to any district headquarters.
Post-Market Surveillance
We collect and analyze post-market feedback via our hospital partner network. Adverse event data is reviewed quarterly by our Quality Management team and fed back into product development cycles.
STANDARDS WE MANUFACTURE TO