https://wiki.dirkjanswagerman.nl/index.php?action=history&feed=atom&title=CFR_21-820.30_-_Design_Controls 2026-10-25T11:16:27Z Revision history for this page on the wiki MediaWiki 1.34.2 https://wiki.dirkjanswagerman.nl/index.php?title=CFR_21-820.30_-_Design_Controls&diff=5545&oldid=prev 2020-08-27T16:54:53Z

<p></p> <table class="diff diff-contentalign-left" data-mw="interface"> <col class="diff-marker" /> <col class="diff-content" /> <col class="diff-marker" /> <col class="diff-content" /> <tr class="diff-title" lang="en"> <td colspan="2" style="background-color: #fff; color: #222; text-align: center;">← Older revision</td> <td colspan="2" style="background-color: #fff; color: #222; text-align: center;">Revision as of 16:54, 27 August 2020</td> </tr><tr><td colspan="2" class="diff-lineno" id="mw-diff-left-l1" >Line 1:</td> <td colspan="2" class="diff-lineno">Line 1:</td></tr> <tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>Read the official FDA guidance to design controls [[http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf|here]]. The CFR regulations described with respect to Design Controls are:</div></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>Read the official FDA guidance to design controls [[http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf|here]]. The CFR regulations described with respect to Design Controls are:</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div> </div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">30a - General</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">30b - Design and development planning</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">30c - Design Input</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">30d - Design Output</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">30e - Design Review</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">30f - Design Verification</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">30g - Design Validation</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">30h - Design Transfer</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">30i - Design Changes</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">30j - Design History File</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">40a - Document approval and distribution</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler.Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">40b - Document Changes</ins>]]</div></td></tr> <tr><td colspan="2"> </td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-840 - Document Controls</ins>]]</div></td></tr> <tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td></tr> <tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>= Overview of Medical Device Design and its Control=</div></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>= Overview of Medical Device Design and its Control=</div></td></tr> <tr><td colspan="2" class="diff-lineno" id="mw-diff-left-l24" >Line 24:</td> <td colspan="2" class="diff-lineno">Line 25:</td></tr> <tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>=Terms=</div></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>=Terms=</div></td></tr> <tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div> </div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">20 - Management Control Flowchart</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">20 - Management Responsibility</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">20a - Quality System</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">20b - Organization</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">20c - Management review</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">20d - Quality Planning</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">20e - Quality System Procedures</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">25 - Personnel</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler</del>.<del class="diffchange diffchange-inline">Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">25 - Personnel - General</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler.Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">CFR 21-820</ins>.<ins class="diffchange diffchange-inline">25 - Personnel - Training</ins>]]</div></td></tr> <tr><td class='diff-marker'>−</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #ffe49c; vertical-align: top; white-space: pre-wrap;"><div>* [[<del class="diffchange diffchange-inline">tiddler.Key</del>]]</div></td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">Device Master File</ins>]]</div></td></tr> <tr><td colspan="2"> </td><td class='diff-marker'>+</td><td style="color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #a3d3ff; vertical-align: top; white-space: pre-wrap;"><div>* [[<ins class="diffchange diffchange-inline">Device Master Record</ins>]]</div></td></tr> <tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"></td></tr> <tr><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>[[Category:fda]]</div></td><td class='diff-marker'> </td><td style="background-color: #f8f9fa; color: #222; font-size: 88%; border-style: solid; border-width: 1px 1px 1px 4px; border-radius: 0.33em; border-color: #eaecf0; vertical-align: top; white-space: pre-wrap;"><div>[[Category:fda]]</div></td></tr> </table>

Dirkjan https://wiki.dirkjanswagerman.nl/index.php?title=CFR_21-820.30_-_Design_Controls&diff=510&oldid=prev 2020-08-25T07:18:27Z

<p>Created page with &quot;Read the official FDA guidance to design controls <a href="/index.php?title=Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf&amp;action=edit&amp;redlink=1" class="new" title="Http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf (page does not exist)">here</a>. The CFR reg...&quot;</p> <p><b>New page</b></p><div>Read the official FDA guidance to design controls [[http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf|here]]. The CFR regulations described with respect to Design Controls are:<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> <br /> = Overview of Medical Device Design and its Control=<br /> <br /> <br /> <br /> &lt;html&gt;&lt;img src = &quot;/static/files/FDA/82030a.jpg&quot; width=&quot;400&quot;/&gt;&lt;/html&gt;<br /> <br /> <br /> <br /> =Terms=<br /> <br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> * [[tiddler.Key]]<br /> <br /> [[Category:fda]]</div>

Dirkjan