conformity-assessment
2 free lessons tagged conformity-assessment across Law & Compliance, Business. Each one is a short sequence of focused steps with narration and a five-question quiz at the end — take them in any order, no signup required.
Proving It: Conformity Routes, Documentation, and Enforcement
Meeting the essential requirements is not the same as being able to show it. This lesson covers the Annex VIII modules and which one each tier allows, the harmonised-standards lever that keeps class I self-assessable, the public-documentation route open to open-source manufacturers, what Annex VII must contain, when a modification restarts the assessment, and the three penalty tiers.
Conformity Assessment, CE Marking, and Life After Launch
A high-risk system reaches the market through a defined gate and stays there under continuing obligations. This lesson covers which conformity assessment procedure applies and when a notified body is involved, the declaration of conformity and CE marking, registration, substantial modification and reassessment, post-market monitoring, and serious incident reporting with its tiered deadlines.