Dirkjan at 16:54, 27 August 2020

2020-08-27T16:54:40Z

Dirkjan: Created page with "The CFR regulations described with respect to Management Responsibility are: * tiddler.Key * tiddler.Key * tiddler.Key * tiddler.Key * tiddler.Key * tidd..."

2020-08-25T07:18:17Z

Created page with "The CFR regulations described with respect to Management Responsibility are: * tiddler.Key * tiddler.Key * tiddler.Key * tiddler.Key * tiddler.Key * tidd..."

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The CFR regulations described with respect to Management Responsibility are:
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The FDA preannouncement call will request a copy of:
* the firm's [[CFR 21-820.20e - Quality System Procedures|quality policy system procedure]]
* The [[Quality Manual|Quality Manual]]
* The [[Quality Plan|Quality Plan]]

=FDA Inspection=
* The investigators will review the written [[Quality Policy|Quality Policy]] and will assess it to ensure that it defines tthe firm's overall quality intention
* The investigators will determine whether the firms [[Management with executive responsibility|Management with executive responsibility]] ensures that the quality policy is understood at all levels of the organization.
* Investigators will determine whethere management reviews and quality audits are being conducted in correspondence with written procedures.
* They will evaluate the firms [[Quality Plan|Quality Plan]] to determine if the firm's quality practices, resources and activities are relevant and specific to the regulated medical devices that are manufactured.

Each manufacturer must prepare and implement all activities the applicable requirements of the [[Quality System Regulation|Quality System Regulation]] that are necceary to assure that the device, the design process, the manufacturing process and all related activities conform to approved specifications.

=Management Representative=
The FDA expects that a firm has a documented ''management representative'' that has review and approval responsibility for appropriate milestones in the quality system. Investigators will assess a firms:
* Organizational Chart
* Quality Manual
* [[Design Control Activities|Design Control Activities]]
* Complaint Procedures
* Medical Device reporting procedures
* [[Quality Audit Procedure|Quality Audit Procedure]] and schedule
* Quality reaudits, audit reports and corrective and preventive actions.

The management representatives 'fingerprints' should be all over these activities.

{{:CFR 21-820.20 - Management Control Flowchart}}

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 The CFR regulations described with respect to Management Responsibility are:
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+* [[CFR 21-007 - Enforcement Policy - Recalls]]
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+* [[CFR 21-011 - Electronic Records; Electronic Signatures]]
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+* [[CFR 21-1010 - Performance Standards for Electronics Products]]
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+* [[CFR 21-801 - Labeling]]
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+* [[CFR 21-803 - Medical Device Reporting]]
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+* [[CFR 21-806 - Medical Devices; reports of corrections and removals]]
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+* [[CFR 21-807 - Establishment Registration and Device Listing]]
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+* [[CFR 21-814 - Premarket Approval of Medical Devices]]
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+* [[CFR 21-820 - Quality System Regulations]]
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+* [[CFR 21-820.20 - Management Control Flowchart]]
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+* [[CFR 21-820.20 - Management Responsibility]]
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+* [[CFR 21-820.20a - Quality System]]
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+* [[CFR 21-820.20b - Organization]]
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+* [[CFR 21-820.20c - Management review]]
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+* [[CFR 21-820.20d - Quality Planning]]
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+* [[CFR 21-820.20e - Quality System Procedures]]
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+* [[CFR 21-820.25 - Personnel]]
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+* [[CFR 21-820.25 - Personnel - General]]
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+* [[CFR 21-820.25 - Personnel - Training]]
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+* [[CFR 21-820.30a - General]]
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+* [[CFR 21-820.30b - Design and development planning]]
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+* [[CFR 21-820.30c - Design Input]]
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+* [[CFR 21-820.30d - Design Output]]
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+* [[CFR 21-820.30e - Design Review]]
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+* [[CFR 21-820.30f - Design Verification]]
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+* [[CFR 21-820.30g - Design Validation]]
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+* [[CFR 21-820.30h - Design Transfer]]
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+* [[CFR 21-820.30i - Design Changes]]
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+* [[CFR 21-820.30j - Design History File]]
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+* [[CFR 21-820.40a - Document approval and distribution]]
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+* [[CFR 21-820.40b - Document Changes]]
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+* [[CFR 21-821 - Medical Device Tracking Requirements]]
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+* [[CFR 21-840 - Document Controls]]
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+* [[CFR 21-860 - Medical Device Classification Procedures]]
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+* [[CFR 21-861 - Procedures for Performance Standards Development]]
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+* [[CFR 21-892 - Radiological Devices]]
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+* [[CFR 21-895 - Banned Devices]]
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+* [[Device Master File]]
 The FDA preannouncement call will request a copy of:

CFR 21-820.20 - Management Responsibility - Revision history

Dirkjan at 16:54, 27 August 2020

Dirkjan: Created page with "The CFR regulations described with respect to Management Responsibility are: * tiddler.Key * tiddler.Key * tiddler.Key * tiddler.Key * tiddler.Key * tidd..."