An Organization
Dedicated to Quality

Affinity’s commitment to meet or exceed the world’s most demanding quality standards, such as AAMI EC-53 compliance, assures that the requirements of your application will be met.

• ISO13485
• IPC-610 and IPC-620
• FDA Registered and Audited to Quality System Requirements (QSR)
• AAMI (EC-13, EC-53, EC-38)
• Medical Device Directive (CE Mark)
• IEC 60601
• FDA 21CFR898

Medical Connectors

Ruggedized Connectors

Patient Monitoring Cable Assemblies