> MANUFACTURING ABILITIES

MANUFACTURING ABILITIES

SUBMED has been manufacturing high quality products in its 2200 sqm. manufacturing plant. Our abilities in manufacturing are:

Final Assembly             : Assembly in own manufacturing area (ISO Class 8 Clean Room)

Sub-Manufacturing        : Treatment of raw materials is handled in own premises

Production Technology   : Own equipment for die cutting, automatic folding, EO sterilization, blister packing (thermoform packing line), manual packing (via rotary sealers)

Our manufacturing devices and process flow has been strictly controlled according to World Standards:

Quality Management Systems

EN ISO 9001

EN ISO 13485

Product Certifications & Compliances

CE 93/42/MDD

Compliance with ASTM F 1980

Compliance with ASTM F 1929

Compliance with EN 868-5:2009

Compliance with EN ISO 11737-2

Production Area Compliances

EN ISO14698-1

EN ISO 14698-2

Machinery Compliances

EN ISO IEC 17025