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Across
  1. 5. The EU database that’s always “coming soon.”
  2. 7. Something ISO 14971 says you should manage, not ignore.
  3. 10. Where complaints and mistakes go to be “fixed.”
  4. 11. The surprise party you never wanted.
  5. 13. The act of respecting the laws
  6. 15. Annex I’s shopping list of must-haves.
Down
  1. 1. A code that follows your device like a tattoo.
  2. 2. The “after sales” surveillance nobody budgets enough for.
  3. 3. EU regulation replacing the old MDD.
  4. 4. The three letters every manufacturer must tattoo internally.
  5. 5. Instructions for Use that went paperless (and keep IT awake).
  6. 6. What regulators read before patients do.
  7. 8. Three letters you mumble when talking about 13485.
  8. 9. The American uncle who also has opinions.
  9. 12. The cousin that makes IVD people cry at night
  10. 14. These bodies act like VIP clubs—invitation only.