Quality Management System
provider · high risk · Article 17
Establish, implement, document and maintain a quality management system to ensure and demonstrate conformity with this Regulation.
How to satisfy it: ISO 9001-compliant QMS covering design, development, testing, validation, documentation and maintenance.
Article 17 on EUR-Lex · as of 2026-08-03 · Regulation (EU) 2024/1689 as amended by Regulation (EU) 2026/1744