Service & Quality

_____ QUALITY _____

The buyer shall report any individual adverse event or incident to Imaginalis whitin two calendar days. For all other custumer complaints within five working days. Reporting of individual custumer complaints, adverse event or incident must be performed by using the proper module “Custumer Complaint Form“.   Download CCF

The form shall be filled, signed and forwarded to Quality Assurance Department by email to quality@imaginalis.it

In addition to sending invidual report forms, every three months the buyer will forward to Imaginalis Quality Assurance office the resume list of complaints received by buyer in the last quarter, along with buyer internal log references. Alternatively buyer will confirm to Imaginalis the absolute lack of customer complaints and adverse events in that reference quarter. Also in this case the buyer shall send the documentation to quality@imaginalis.it

The buyer shall promptly, but non later than five calendar working days, notify us when an FDA, or other different national authorities, inspection of its facilities related to Imaginalis’s products is expected and / or underway. A copy of inspection results and regulatory correspondences shall promptly send to Imaginalis as well at quality@imaginalis.it

_____ SERVICE _____

Traceability Records about first installation shall include at least the following information:

  1. REF Codes (Part Numbers)
  2. Model Names
  3. Serial Numbers / Lots
  4. Dates of installation
  5. Names and locations of installation sites
  6. Name and titles of end user
  7. Name of installation technician

These informations shall be forwarded to Service Department to service@imaginalis.it for first installation and every quarter, in this case with object “Quarterly Traceability News“.

All installation and service activities must be recorded by filling a report that shall be sent to service@imaginalis.it with object: “Technical Assistance on [S/N] machine“. The dedicated form to fill is “Technical Assistance Report“.   Download TAR 

Custumers can also send by email to service@imaginalis.it considerations and / or complains to improve the device or Technical Support.

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