Medical Device Product Performance Specification Procedure
Define and approve measurable medical device product requirements with this editable Product Performance Specification (P-Spec) Procedure and detailed P-Spec form. It guides teams from customer and clinical needs through technical specifications, cross-functional review and controlled revisions for subsequent design verification.
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Supplied as one editable Microsoft Word document in a digital download.
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.
Turning needs into a controlled specification
The product performance specification (P-Spec) procedure starts with customer needs and other inputs such as clinical requirements, comparable-product data, relevant literature and applicable standards. The project team develops measurable performance requirements and identifies how each requirement will be assessed.
Creation, revision and approval
The procedure addresses whether a new P-Spec is needed or an existing one should be revised for a line extension. It covers document status, cross-functional review, approval and revision so the specification remains a controlled input to design and verification.
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.
Use the approved P-Spec alongside the Design Verification and Validation Procedure to plan how specified requirements will be checked.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Design Controls: Requirements, Reviews and Transfer for workflow guidance, a checklist and common mistakes.
