Questions about complaint trending, reporting and CAPA

Direct answers to questions medical device quality and regulatory teams ask about trending complaints, reportability, the risk file and CAPA, each with what MDARIX does about it. General information, not legal or regulatory advice.

1. How do I trend medical device complaints?

   Count clusters, compare each version's rate with its own history, and use units in the field.

2. When does a complaint become a reportable event?

   21 CFR Part 803 and EU MDR Article 87 in brief: what is reportable, by when, and who decides.

3. How should post-market data feed the risk file?

   ISO 14971:2019 clause 10 in brief: review field information for safety and record every risk review.

4. What is the difference between a complaint signal and a trend?

   A trend is a measurement over time; a signal is an observation a person triages.

5. How do I show a CAPA was effective?

   Set the criteria before the action, measure from the right date, and sign what you found.

6. Can I try complaint trending on my own data without a demo call?

   Yes: a free 30-day trial, requested on the website, with sample data first and then your own exports.