English to Italian Other Management medical devices certification

Gentili utenti,

Non riesco a capire il significato preciso di "scope" e "design" in questo ambito:
"For Class II devices the scope can exclude design but, for Classes III and IV, the scope must include design."
Si parla di certificazioni per dispositivi medicali.
Altro contesto (prima e dopo):
1.Our team of auditors reaches around the world, enabling you to partner with us wherever you are based to have your quality management system audited against ISO 13485 and the Canadian medical devices regulations.
The certification process must be completed before you apply for a Health Canada license and commence selling in Canada.
2.Own brand labelers wishing to sell in Canada must also hold ISO 13485 certification under CMDCAS.
Our site audits will assess compliance to ISO 13485:2003 and parts of the Canadian regulations as necessary.
The right medical certification at the right time is the key to winning new contracts, launching new products and entering new markets.

Grazie a tutti in anticipo.