K
Hi All!
We are looking for placing our medical device on the EU market. I am now working with instruction manual for the product.
Mentioning the product Intended Use in the manual is required by many standards.
But the Intended Use for our device is worded more as a legal statement in officialese, so, if placed in the manual as is, it might not make any sense for a lay user to whom the manual is addressed.
Is it Ok to have a simplified wording of Intended Use specifically for the purpose of including it into the user manual? Or shall there be just one and only Intended Use wording for a certain product?
Thanks in advance for the suggestions!
We are looking for placing our medical device on the EU market. I am now working with instruction manual for the product.
Mentioning the product Intended Use in the manual is required by many standards.
But the Intended Use for our device is worded more as a legal statement in officialese, so, if placed in the manual as is, it might not make any sense for a lay user to whom the manual is addressed.
Is it Ok to have a simplified wording of Intended Use specifically for the purpose of including it into the user manual? Or shall there be just one and only Intended Use wording for a certain product?
Thanks in advance for the suggestions!