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Medical Device Design Changes SOP

Quick Overview This Standard Operating Procedure (SOP) describes the requirements associated with making design changes during the Design Control process. This SOP is the essential part of the overall Design Control process.

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5K views1 page

Medical Device Design Changes SOP

Quick Overview This Standard Operating Procedure (SOP) describes the requirements associated with making design changes during the Design Control process. This SOP is the essential part of the overall Design Control process.

Uploaded by

qmdocs
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Quality Management

Documents & Templates

Design Changes
The design change process ensures that changes to a design are accurately identified, documented, reviewed, and approved prior to implementation and appropriately verified and/or validated. Design changes include the following: Pre-release changes that typically begin during the Design Inputs phase and continue throughout Product development Post-release changes that typically begin after the transfer of the design to Manufacturing and continue on throughout the life of the Product.

7.2

Design Changes Sources The design changes typically arise from the following sources: Design Reviews, Design Verification, Design Validation, Software Verification, Software Validation, Manufacturing activities Service records, and/or Customer complaints.

7.3

Design Change Process The design change Process is a step by step approach and is detailed in the corresponding ENGINEERING CHANGE REQUEST Forms Attachments 1-3. For engineering documents generated with the aid of CAD software, signed hard copies are considered the controlled documents

7.4

Classes of Change Class I: minor changes to documentation. This includes the addition of notes, correction of typographical or spelling errors, and the addition of new views or clarification of notes Class II: an engineering change that does not impact the User or Product Requirements Class III: an engineering change that impacts the User or Product Requirements

7.5

Approval of changes The approval needed for Changes depends on the change classification. The Project Leader (PL) / Head of Engineering (HE) determines the appropriate change classification: Class I Revisions: PL /HE approves The Change originator marks up drawing copy with suggested change or verbally describes change to PL /HE.
Document Type SOP Document ID XX_WWW_ZZZ_YYYY Version 1.0 Status Approved Page 7/21

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