Verification

Verification checks that the device meets its specified requirements, while validation checks that it meets user needs and intended use. MDCG 2022-3 uses the term for notified body verification of manufactured class D IVDs.

confirmation, through the provision of objective evidence (3.11), that specified requirements have been fulfilled Note 1 to entry: The objective evidence needed for a verification can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents. Note 2 to entry: The activities carried out for verification are sometimes called a qualification process. Note 3 to entry: The word “verified” is used to designate the corresponding status. [SOURCE: ISO/IEC Guide 63:2019, 3.19]

ISO 14971:2019, clause 3.31

confirmation, through the provision of objective evidence, that specified requirements have been fulfilled Note 1 to entry: The objective evidence needed for a VERIFICATION can be the result of an inspection or of other forms of determination such as performing alternative calculations or reviewing documents. Note 2 to entry: The activities carried out for VERIFICATION are sometimes called a qualification process. Note 3 to entry: The word “verified” is used to designate the corresponding state. [SOURCE: ISO 9000:2015, 3.8.12]

IEC 82304-1:2016, clause 3.24

confirmation through provision of objective evidence that specified requirements have been fulfilled NOTE 1 “Verified” is used to designate the corresponding status. [ISO 9000:2000, definition 3.8.4] NOTE 2 In design and development, VERIFICATION concerns the PROCESS of examining the result of a given ACTIVITY to determine conformity with the stated requirement for that ACTIVITY.

IEC 62304:2006+AMD1:2015, clause 3.33

confirmation by examination and provision of objective evidence that specified requirements have been fulfilled

ISO 14155:2020, clause 3.54

Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.

MDCG 2022-3 Rev.1, Section 3, Definitions (3.5; source: EN ISO 9000:2015)