Complaint intake that survives an audit

• One channel-agnostic record for every contact, whether phone, email, chat or distributor.
• Captured fields: device identifier, lot or serial, event description, patient impact, date.
• Immediate flagging of injury, malfunction, or use error for evaluation.
• A written procedure defining what counts as a complaint and who evaluates it.
• Retention that matches regulatory requirements and is retrievable by device and lot.

MDR reportability and timelines

Medical device reports are required for events that reasonably suggest a device has caused or contributed to a death or serious injury, or where a malfunction would be likely to cause such an outcome if it recurred. The evaluation must be documented even when the answer is that no report is required, because the assessment itself is the record an investigator will ask for.

• 30 calendar days for most reportable events.
• 5 calendar days where remedial action is needed to prevent a substantial impairment, or where FDA has requested a report.
• Documented rationale for every event assessed as not reportable.

White-label support without losing control

Support delivered under your brand is a customer experience decision, not a regulatory boundary. Your company remains responsible for complaint evaluation and reporting unless those responsibilities are formally delegated in a quality agreement, and even then the reporting record has to be complete. Agree the escalation path, the report format and the response times in writing.

Trends are the point

Individual complaints are handled; trends prevent the next one. Review complaint categories monthly, compare against shipped volume, and feed recurring issues into corrective action. A support operation that produces a trend report is an asset to the quality system rather than an intake queue.