Medical Device Product Performance Specification Procedure
The Medical Device Product Performance Specification Procedure provides a process for documenting product requirements in the form of a product performance specification (P-Spec) in accordance with requirements of ISO 13485:2016, FDA QMSR and MDR (EU) 2017/745. The procedure includes a detailed P-Spec Form/Document.
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Product Performance Specification Procedure
The Medical Device Product Performance Specification Procedure provides a process for documenting product requirements in the form of a product performance specification (P-Spec) in accordance with requirements of ISO 13485:2016, FDA QMSR and MDR (EU) 2017/745. The procedure includes a P-Spec Form.
Product Performance Specification Procedure - Overview
The Medical Device Product Performance Specification Procedure outlines the process for development of technical specifications and assigns departmental responsibilities to P-Spec development tasks. The procedure outlines 16 critical product considerations (e.g. Indications for use; clinical procedure; patient interface; equipment interface; physical characteristics; etc.) and includes questions for each consideration to aide development teams.
Regulatory framework
For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.
