Transcription of QUALITY ASSURANCE MANUAL
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A/FATRONICS International LimitedQuality ASSURANCE MANUAL , Rev UQUALITY ASSURANCE MANUALUNCONTROLLED COPYThis MANUAL contains information proprietary to Theratronics International Limited. Any disclosure or use of this information or any reproduction of this MANUAL other than for the specific purpose for which it is intended is expressly prohibited except as THERATRONICS may otherwise agree in 19977 MRTRONICS International LimitedQuality ASSURANCE MANUAL , Rev UQUALITY POLICY We will respond to the needs and expectations of our customers by: ".
in the Software Quality Assurance Manual, 5.07-AA-00. 1.2 REGULATORY AND QUALITY SYSTEM COMPLIANCE The Theratronics Quality Assurance Program is compliant with ISO 9001, EN 46001, the U.S. Federal Food and Drug Administration GMP Program, Health Canada Medical Device Regulations, European Medical Device Directive 93/42/EEC and Canadian
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