9. Frequently asked questions
Is there a standard life sheet template recognized by the authorities?
To date, there is no standard sheet recommended by the Administration. EXERA presented an example of a life sheet at the December 6, 2012 event held in LYON (a day organized by EXERA dedicated to the management of MMRI in industry and regulatory developments for SIS). Each manufacturer is free to define its own life sheet template.
What's the difference between an inspection or surveillance plan and an inspection or surveillance program?
Article 2 of
arrêté du 4 octobre 2010
differentiates between these two concepts:
...
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Frequently asked questions