Medical device quality glossary

Short, sourced definitions of the terms that show up in ISO 13485, MDSAP, EU MDR and FDA QMSR work. Each entry says how the term is used and what HAVGATE does or does not cover.

These entries are educational. They are not the text of the standard or the regulation. When a deadline, a class rule or a grade timeline matters, read the current official document. HAVGATE is a new company and does not illustrate these terms with customer stories.