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 Test Plan (Created page with "In FDA Design Controls the '''''Test Plan''''' is a step-by-step plan to be followed during the verification or validaton of a product or p...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Table-Top Inspection (Created page with "A ''Table-Top Inspection'' is an inspection strategy of reviewing a firms written procedures and perhaps records from a fixed location, such as an office or table-top and not...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Specification (Created page with "In FDA Design Controls the '''''Specification''''' means any requirement with with which a product, process, service, or o...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Software Verification (Created page with "Software verification provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements f...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Software Validation (Created page with "'''Software Validation''' is a part of the Design Validation for a finished device, but is not separately defined in the Quality System regulation. For p...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Situation I (Created page with "In FDA Inspections Situation I conditions are those conditions that provide evidence that there are significant errors in the manufacturers production proc...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page SSRMM (Created page with "Sub System Risk Management Matrix Category:fda Category:Term")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Risk Analysis (Created page with "In FDA Design Controls '''''Risk Analysis''''' is the ongoing investigation of the available inormation to identify hazards and estimate t...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Requirements (Created page with "In FDA Design Controls the '''''Master Verification''''' are documented functions, conditions, or capabilities that a medical device must m...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page RMM (Created page with "Risk Management Matrix Category:fda Category:Term")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Quality System Inspection Technique (Created page with "The Quality System Inspection Technique (QSIT) provides guidance to the FDA field staff on a new inspectional process that may be used to assess a medical device manufacturer'...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Category:QSIT (Created page with "{{category}}")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Quality System (Created page with "A ''Quality System'' means the organizational structure, responsibilities, procedures, processes and resources for implementing quality management. Quality System includes al...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Quality Policy (Created page with "In the FDA's Quality System Requirements ''Quality Policy'' means the overall quality intentions and direction of an organization with respect to Quality by Mana...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Quality (Created page with "In the FDA's Quality System Requirements ''Quality'' means the totality of features and characteristics tha bear on the ability of a device to satisfy fitness for use, includi...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Production Specifications (Created page with "'''Production specifications''' must ensure that manufactured devices are repeatedly and reliably produced within product and process capabilities. One normally associates the...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Product Proposal (Created page with "The Design Control Activities start with the ''output'' of the concept phase as the Design Input, this output is sometimes called the Product Proposal|Produ...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Premarket notification (Created page with "Premarket notification or 510(k) is a process by which a submitter notifies the FDA at least 90 days prior to the submitters inroduction of any appropriate device (...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Premarket approval (Created page with "Premarket approval (PMA) is a process by which Class II Medical Devices are approved to enter into interstate commerce. Typically, a PMA r...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page PMA (Created page with "PMA is an abreviation for Premarket approval and is required for Class II Medical Devices Category:fda [[Category:FDA]...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Medical Device Report (Created page with "In FDA Design Controls the '''''Medical Device Report''''' (MDR) means Medical Device Reporting. To be elaborated... Category:fda Ca...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Mastering and Managing the FDA Maze (Created page with "<<formTiddler <missing '>>'>NewBookTemplate>> <html> <iframe src="http://rcm.amazon.com/e/cm?t=httptiddlyweb-20&o=1&p=8&l=as1&asins=0873894553&ref=tf_til&...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Master Verification Plan (Created page with "In FDA Design Controls the '''''Master Verification''''' or Validation Plan is a document that identifies all responsibilities, expectation...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Management with executive responsibility (Created page with "In the FDA's Quality System Requirements ''Management with executive responsibility'' means those senior employees of a manufacturer who have the authority to Establish|Esta...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Letter to File (Created page with "lso known als Not to file. Its a procedure that documents why a manfactures believes he is not eligible to file 510(k) Category:fda Category:...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Legal Owner (Created page with "The Legal Owner is the entity that is responsible for the DMS and DHF. The production site is the Legal Owner Category:fda Category:Term")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Intended use (Created page with "Intended use is the objective intent of the manufacturer or person(s) legally responsible for the labelling of devices and includes labeling claims, advertising amtter, and or...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page ISO 9001 (Created page with "A specific generic international conformance standard to which a firm involved with design, development, production, installation and servicing may comply and be found complia...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page ISO 9000 (Created page with "ISO 9000 is a group of generic international standards for quality management, quality assurance and implementation of a quality system. Category:fda Category:Term")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Human Factors (Created page with "In FDA Design Controls '''''Human Factors''''' are those design activiies that addres the human interface, for example, the device and the...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page General Controls (Created page with "In FDA regulation, general controls include: # An establishments FDA registration form FDA 2891 # Product listing form FDA 2892 # Compliance with FDA...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Fault Tree Analysis (Created page with "In FDA Design Controls '''''Fault Tree Analysis''''' (FTA) is a systematic inductive technique that diagrams information on a system and ca...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Failure Mode, Effect and Criticality Analysis (Created page with "In FDA Design Controls '''''Failure Mode, Effect and Criticality Analysis''''' (FMECA) is FMEA process...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Failure Mode and Effect Analysis (Created page with "In FDA Design Controls '''''Failure Mode and Effect Analysis''''' (FMEA) is and inductive technique that assesses the frequency and consequ...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page FDA Inspections (Created page with "To understand FDA Inspections the following concepts & definitions are important during inspections: * A Bottum-up inspection was the FDA standard ins...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page FDA Design Traceability (Created page with "<youtube>iB8JDuHTdIk</youtube> Category:fda Category:Video")
• 07:19, 25 August 2020 Dirkjan talk contribs created page FDA 483 (Created page with "The form FDA 483, Notice of inspection os the form the FDA present to firms as the conclusions of an inspection. You can find the form http://www.fda.gov/downloads/ICECI/Ins...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page FDA 482 (Created page with "In FDA Inspections Form 482, notice of inspections is the form the FDA presents to firms prior to an inspection. Typically this form is presented to the senior management indi...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Category:Form (Created page with "{{category}}")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Establishment Inspection Report (Created page with "The Establishment Inspection Report (EIR) is the report completed by the FDA investigatprs after an inspection os completed an forwarded to their district office. The report i...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Establish (Created page with "In the FDA's Quality System Requirements ''Establish'' means define, document (in writing or electronically), and implement Category:fda Category:FDA Category:Qual...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Document Control (Created page with "In the FDA Design Controls '''''Document Control''''' is the enumeration of design documents, and tracking their status and revision history. Throughout t...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Directed inspection (Created page with "A ''Directed Inspection'' is an inspection performed on specific elements of a firm's quality system subject to FDA jurisdiction, as identified by agency manuals, assignments,...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Differences ISO 9000 and FDA quality system (Created page with "There are several major differences: * FDA regulations are the federal law! * ISO 9000 consist of volontary quality standards, which manufacturers comply and docu...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Device classification (Created page with "In FDA Regulations there are three types of device: <html><img src = "/static/files/FDA/Device%20Classification.jpg" width="600"/></html> =Class I Medical Devices= {{:Clas...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Category:Mastering and Managing the FDA Maze (Created page with "{{category}}")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Category:DFA (Created page with "{{category}}")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Device Master Record (Created page with "In the FDA Regulations a '''Device Master Record''' (DMS) means a compilation of records containing the prodedures and specifications for a finishe...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Device Master File (Created page with "In the FDA Regulations a '''Device Master File''' (DMF) means a compilation of records describing the design history of a finished device. Compare Devi...")
• 07:19, 25 August 2020 Dirkjan talk contribs created page Detailed Design Documents (Created page with "In FDA Design Outputs the Detailed Design Documents should include the following: * Schematics * Device components * Subassemblies Catego...")

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