All public logs

Combined display of all available logs of knowledgebase. You can narrow down the view by selecting a log type, the username (case-sensitive), or the affected page (also case-sensitive).

(newest | oldest) View (newer 50 | older 50) (20 | 50 | 100 | 250 | 500)

• 07:19, 25 August 2020 Dirkjan talk contribs created page Design Output (Created page with "In FDA Design Controls a '''''Design Output''''' means the result of a design effort at each design phase and at the end of the total desig...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Design Master Record (Created page with "In the FDA's Quality System Requirements the ''Design Master Record'' (DMR) means a compilation of records containting the procedures and specifications for a finished device....")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Design Input Requirements Control Matrix (Created page with "A ''Design Input Requirements Control Matrix'' is a Controlled Document that identifies in a tabular format each device input requirements. The matrix...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Design Input Document Control Matrix (Created page with "In the FDA Regulations description of the '''Design Input Document Control Matrix''' is regarded to be a good mechanism to control design input documentati...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Design Input (Created page with "In FDA Design Controls '''''Design Input''''' means the physicla and performance requirements of a device that are used as a basis for devi...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Design History File (Created page with "In FDA Design Controls a '''''Design History File''''' (DHF) means a compilation of records which describe the complete history of a finish...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page DMS (Created page with "DMS is an abbreviation for Device Master Record Category:fda Category:Term")
• 07:19, 25 August 2020 Dirkjan talk contribs created page DHF (Created page with "Abbreviation for Design History File Category:fda Category:Term")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Controlled Document (Created page with "In FDA Design Controls a '''''Controlled Document''''' means a document subject to procedural control as well as re...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Comprehensive inspection (Created page with "A ''comprehensive inspection'' is an inspection performed on all elements of a firms quality system subject to FDA jurisdiction, to asses the firms compliance status. Catego...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Class III Medical Devices (Created page with "Class III Medical Devices are devices that cannot be classified as Class I or Class II because: # General and special control do not provide reasonable assurance of their safe...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Class II Medical Devices (Created page with "Class II Medical Devices are more complicated and present greater risk than Class I devices. Class II devices are subject to FDA's General Controls. Furth...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Class I Medical Devices (Created page with "Class I Medical Devices are subject only to the FDA's General Controls because they are the least complicated and present the least risk. The FDA's genera...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Change Order (Created page with "A ''Change Order'' pertains to an explicitly identified document or group of documents, and specifies the detailed revision of the document content which will fix the identifi...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Change Control (Created page with "Manufacturing change control is usually implemented using a set of standardized procedures similar to the following: * A change request identifies a design problem which the r...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page CFR 21-895 - Banned Devices (Created page with "These regulations implement the FDA's responsibilities for and authority over devices identified by the FDA that present substantial deception or an unreasonable and substanti...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page CFR 21-892 - Radiological Devices (Created page with "These regulations implement the FDA's responsibilities for and authority over radiologic medical devices. Category:fda Category:CFR Category:FDA")
• 07:19, 25 August 2020 Dirkjan talk contribs created page CFR 21-861 - Procedures for Performance Standards Development (Created page with "These regulations implement the FDA's responsibilities for and authority over the establishment, amendment and revocation of performance standards for medical devices. Congres...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page CFR 21-860 - Medical Device Classification Procedures (Created page with "These regulations implement the FDA's responsibilities for and authority over classification of devices. {{:Device classification}} Category:fda Category:CFR Cate...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page CFR 21-840 - Document Controls (Created page with "Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The followog terms and concepts are relevant to 21-840 - Do...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-821 - Medical Device Tracking Requirements (Created page with "These regulations implement the FDA's responsibilities for and authority over # Medical devices that are permanently implanted or life sustaining or life supporting # Any othe...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.40b - Document Changes (Created page with "Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifical...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.40a - Document approval and distribution (Created page with "Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The ap...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page Category:Document Controls (Created page with "{{category}}")
• 07:18, 25 August 2020 Dirkjan talk contribs created page Category:CFR 21-820.40 (Created page with "{{category}}")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.30j - Design History File (Created page with "Each manufacturer shall establish and maintain a Design History File (DHF) for each type of device. The DHF shall contain or reference the records nece...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.30i - Design Changes (Created page with "Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design c...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.30h - Design Transfer (Created page with "Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications. =Attention points= * Learn a...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.30g - Design Validation (Created page with "Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.30f - Design Verification (Created page with "Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.30e - Design Review (Created page with "Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.30d - Design Output (Created page with "Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.30c - Design Input (Created page with "Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the devic...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.30b - Design and development planning (Created page with "Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans s...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.30a - General (Created page with " Each manufacturer of any class III or class II device, and the class I devices listed b...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.30 - FDA Inspection Guidelines (Created page with "Under the QSIT handbook, investigators will regard Design Controls as one of the four major quality systems for each form. The following steps are...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page Category:Section (Created page with "{{category}}")
• 07:18, 25 August 2020 Dirkjan talk contribs created page Category:Quality System Requirements (Created page with "{{category}}")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.30 - Design Controls (Created page with "Read the official FDA guidance to design controls here. The CFR reg...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.25 - Personnel - Training (Created page with "Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Tr...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.25 - Personnel - General (Created page with "Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are co...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.25 - Personnel (Created page with "The CFR regulations described with respect to Personnel are: * tiddler.Key * tiddler.Key * tiddler.Key * tiddler.Key * tiddler.Key * tiddler.Key * ti...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page Category:CFR 21-820.25 (Created page with "{{category}}")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.20e - Quality System Procedures (Created page with "Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.20d - Quality Planning (Created page with "Each manufacturer shall establish a Quality Plan which defines the quality practices, resources, and activities relevant to devices that are designed and manu...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.20c - Management review (Created page with "Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.20b - Organization (Created page with "Each manufacturer shall establish and maintain an Adequate Organizational Structure to ensure that devices are designed and produced in a...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.20a - Quality System (Created page with "Management with executive responsibility shall Establish its policy and objectives for, and commitment to, quality....")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.20 - Management Responsibility (Created page with "The CFR regulations described with respect to Management Responsibility are: * tiddler.Key * tiddler.Key * tiddler.Key * tiddler.Key * tiddler.Key * tidd...")
• 07:18, 25 August 2020 Dirkjan talk contribs created page CFR 21-820.20 - Management Control Flowchart (Created page with "The management control flow chart indicates which steps may be taken during FDA Inspection <html><img src = "/static/files/FDA/ManagementControlFlowChart....")

(newest | oldest) View (newer 50 | older 50) (20 | 50 | 100 | 250 | 500)