In The Navigator you classified an AI system. This is what happens next. You run engineering at a company whose product just landed in the high-risk tier — and for the next eighteen months, every decision you make either builds your paper trail or burns it. Five acts, scored, with the real article behind every answer.
• SkillRank is already on the market — you're not launching, you're retrofitting compliance.
• The model is built in-house on candidate data from customers; a hosted LLM writes candidate summaries.
• You have: a data science team of six, one overworked compliance officer (Priit), and a CEO who reads the fines table before breakfast.
• What you don't have yet: a QMS, technical documentation, a post-market monitoring plan, or any idea what "conformity assessment" means for a company your size.
Real conformity work is slower and lumpier than five acts: standing up a QMS takes months, notified-body queues (where they apply) run long, and the standards landscape is still settling. Three honest simplifications:
• We compressed role nuances — importer and distributor duties (Art 23–24) never entered the story.
• The serious-incident definition and windows have more structure than one decision can carry (Art 3(49), Art 73) — the lesson that survives compression: establish the causal link, then the clock is already running.
• Registration mechanics (Art 49, Annex VIII) got one checklist line; in reality the EU database has its own workflow.