Design Change Procedure
The Design Change Procedure walks a project team through assessing a proposed change during development or after release, documenting its effect on design requirements and records, and obtaining the appropriate cross-functional and regulatory review before implementation.
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Editable Microsoft Word procedure supplied as a digital download. Adapt responsibilities and workflows to your organization before approval and implementation.
Evaluating the proposed change
The design-change process distinguishes modifications made during development from changes proposed after commercial release. The project team evaluates the effect on specifications, intended use, design outputs, risk controls and prior verification or validation before deciding what new work is needed.
Review and implementation
Regulatory Affairs assesses the regulatory effect while engineering and quality review the design evidence and affected documentation. The decision, approvals and implementation route are recorded through the applicable design-control and engineering-change processes.
Related change evidence
Use the Design Analysis Procedure to examine product and process risks, the Design Verification and Validation Procedure for applicable test evidence, and the Engineering Change Notice Procedure for controlled implementation and document revisions.
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.
