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Medical Device Certifications

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Arterex Medical

FDA Registered Quality
ISO 13485 certification logo for Quality Management System (QMS), featuring the International Organization for Standardization (ISO) globe symbol with “ISO 13485” text, representing medical device quality standards and compliance.
ISO 14001 certification logo for Environmental Management System (EMS), featuring the International Organization for Standardization (ISO) globe symbol and “ISO 14001” text, representing environmental compliance and sustainability standards.
ISO 9001 certified badge logo for Quality Management System (QMS), featuring a globe emblem with “ISO 9001 Certified” text, representing quality assurance, process improvement, and international quality standards compliance.
ISO Class 7 Cleanrooms
ISO Class 8 Cleanrooms
(EN ISO 14644-1)

Arterex - Injection molding, Tooling, Metals + Device Assembly
(Formerly Adroit USA)

FDA Registered Quality
ISO 13485 certification logo for Quality Management System (QMS), featuring the International Organization for Standardization (ISO) globe symbol with “ISO 13485” text, representing medical device quality standards and compliance.
ISO 9001 certified badge logo for Quality Management System (QMS), featuring a globe emblem with “ISO 9001 Certified” text, representing quality assurance, process improvement, and international quality standards compliance.
ISO Class 7 Cleanrooms
ISO Class 8 Cleanrooms
(EN ISO 14644-1)

Arterex - Injection molding, Tooling, Metals + Device Assembly
(Formerly Formula Plastics)

FDA Registered Quality
ISO 13485 certification logo for Quality Management System (QMS), featuring the International Organization for Standardization (ISO) globe symbol with “ISO 13485” text, representing medical device quality standards and compliance.
ISO 14001 certification logo for Environmental Management System (EMS), featuring the International Organization for Standardization (ISO) globe symbol and “ISO 14001” text, representing environmental compliance and sustainability standards.
ISO Class 8 Cleanrooms
(EN ISO 14644-1)

Arterex - Electromechanical Device Development + Device Assembly
(Formerly NextPhase)

FDA Registered Quality

Mansfield MA

Rochester NH

Tijuana MEXICO

ISO 13485 certification logo for Quality Management System (QMS), featuring the International Organization for Standardization (ISO) globe symbol with “ISO 13485” text, representing medical device quality standards and compliance.

Mansfield MA

Rochester NH

Tijuana MEXICO

ISO Class 7 Cleanrooms
ISO Class 8 Cleanrooms
(EN ISO 14644-1)

Arterex - Specialty Extrusion
(Formerly Xponent Global)

ISO 9001 certified badge logo for Quality Management System (QMS), featuring a globe emblem with “ISO 9001 Certified” text, representing quality assurance, process improvement, and international quality standards compliance.

Kabo, An Arterex Company

ISO 13485 certification logo for Quality Management System (QMS), featuring the International Organization for Standardization (ISO) globe symbol with “ISO 13485” text, representing medical device quality standards and compliance.
ISO 9001 certified badge logo for Quality Management System (QMS), featuring a globe emblem with “ISO 9001 Certified” text, representing quality assurance, process improvement, and international quality standards compliance.
Directive 93/42/ ECC
CE Mark
ISO Class 8 Cleanrooms
(EN ISO 14644-1)

Luc & Bel, An Arterex Company

ISO 13485 certification logo for Quality Management System (QMS), featuring the International Organization for Standardization (ISO) globe symbol with “ISO 13485” text, representing medical device quality standards and compliance.
ISO Class 8 Cleanrooms
(EN ISO 14644-1)
ISO 80369-7
Part 7: Connectors for intravascular or hypodemic applications

ModenPlast, An Arterex Company

ISO 13485 certification logo for Quality Management System (QMS), featuring the International Organization for Standardization (ISO) globe symbol with “ISO 13485” text, representing medical device quality standards and compliance.
ISO 9001 certified badge logo for Quality Management System (QMS), featuring a globe emblem with “ISO 9001 Certified” text, representing quality assurance, process improvement, and international quality standards compliance.
ISO Class 8 Cleanrooms
(EN ISO 14644-1)

Phoenix, An Arterex Company

ISO 13485 certification logo for Quality Management System (QMS), featuring the International Organization for Standardization (ISO) globe symbol with “ISO 13485” text, representing medical device quality standards and compliance.
ISO Class 8 Cleanrooms
(EN ISO 14644-1)
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