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Validation | Re-qualification Services

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Performance Qualification and Compliance

With the looming changes to AS/NZS 4187 standards approaching in year 2020, a lot of questions arise with equipment validation and what needs to be covered, by when, how etc.

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Traditionally, Gallay Medical & Scientific have provided service, maintenance and after-market services, whilst performing validation services in CSSD.  We are please that we can now extended those services to performance qualification in your Endo Suite and/or Reprocessor.

These Performance Qualification reports with routine site assesments and preventative maintenance scheduling, include all the areas required to meet machine compliance, as referenced in Table 10.3, Recommended Frequency for Recalibration, Preventative Maintenance and Testing of Automated Endoscope Reprocessors (AER) in AS/NZS 4187:2014.

Would like to know more?  Contact Gallay to have a performance qualification tailored to meet your specific requirements.