Verification, Validation, and Process Validation Are Three Different Things

These three get blended in conversation constantly. Blending them creates audit findings. Design Verification confirms the Design Output met the Product Requirement.

These three get blended in conversation constantly. Blending them creates audit findings.

Design Verification confirms the Design Output met the Product Requirement.

Did we build the device right?

Design Validation confirms the device meets User Needs and Intended Uses in actual or simulated use.

Did we build the right device?

Process Validation confirms the manufacturing process makes conforming product consistently.

Can we build it the same way every time?

Different questions. Different evidence. Different acceptance criteria.

Verification tests a number. Tensile strength. Flow rate. Electrical isolation.

Validation tests the use. The clinician, the patient, the environment, the workflow.

Process Validation tests the line. IQ, OQ, and PQ (Installation, Operational, and Performance Qualification).

21 CFR 820.10(c) and ISO 13485 Sections 7.3.6 and 7.3.7 cover Design Verification and Design Validation.

Section 7.5.6 covers Process Validation.

The standard keeps them in separate clauses for a reason.

Mix them in your protocols and a reviewer will untangle them for you, in writing, as a deficiency.

Name each activity for what it proves. Then your submission tells one clean story.

#MedicalDevices #DesignControls #ProcessValidation #ISO13485 #QMSR #MedTech