Complaint

A complaint is an allegation that a device, or something about its identity, quality, durability, reliability, safety or performance, is deficient.

ISO 13485 clause 8.2.2 and the matching US requirements expect a procedure, an evaluation of whether the event is reportable, and records. MDSAP Chapter 3 samples complaint handling and the decision to report. A sales email is not a complaint record until someone captures it in the complaint process.

HAVGATE's CRM stores contacts and pipeline work. It does not open a CAPA from a CRM message. If a customer complaint arrives by email, a person still has to log it in the quality process. That gap is stated on the CRM page.