TriE's Standards

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Quality / Regulatory

TriE Medical, Inc. has experience in providing support documentation for submission and compliance in the following areas:

FDA, QSR

ISO 9001, 9002

EN46001, 46002

FDA Class I, II, III

Product Testing

Test Strategy Development

Manufacturing Defect Analysis

In-Circuit Test Systems

Functional Test Equipment

Environmental Stress Testing

Shipping, Vibration Testing

Immunity Testing

Emissions Testing IEC 601-1-2

EN60601-1, EN60601-1-2, EN55011, EN60601-1-4

Product Verification / Validation

FMEA (Failure Mode Effects Analysis)

Test Reports Directly Tired to FMEA Analysis

Saftey / Hazard Review

Process Validation

Software Verification / Validation