Audit Task 7 is to review medical device specifications to confirm that design and development outputs are traceable to and satisfy design input requirements.

Identification

In addition, verify that the design and development outputs essential for the proper functioning of the medical device have been identified.

Outputs include, but are not limited to:

• Device specifications
• Specifications for the manufacturing process
• Specifications for the sterilization process (if applicable)
• The quality assurance testing
• Device labeling and packaging

What The Auditor Will Be Thinking!

During the review of a design project, the audit team should be mindful of production processes and supplied products that are essential to the proper functioning of the device. Production processes can include not only the manufacturing instructions, but also internal controls, such as the type and extent of acceptance activities, equipment calibration and maintenance intervals, environmental controls, and personnel controls.

Essential Design Outputs

For suppliers that provide products and services related to the essential design outputs, the degree of purchasing controls necessary is commensurate with the effect of the supplied products on the proper functioning of the finished device.

During the audits of the Purchasing process and Production and Service Controls process, the audit team should consider reviewing production processes and supplied products that have the highest risk or greatest effect on the essential design outputs.