If the product is cleaned in accordance with clause (a) or clause (b) above, the requirements content in clauses (a) and (b) of sub-paragraph 6.4 do not apply prior to the cleaning process. 7.5.1.2.2 Installation activities If appropriate, the manufacturer shall establish documented requirements which contain acceptance criteria for installing and verifying the installation of the medical device o ...

Design and development verification: Verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained.