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• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (b)(6) Override capability (Created page with "''(6) Override capability'' If the fluoroscopic x-ray field size is adjusted automatically as the SID or image receptor size is changed, a capability may be provided f...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (b)(3) Non-image-intensified fluoroscopy (Created page with "''(3) Non-image-intensified fluoroscopy'' The x-ray field produced by non-image-intensified fluoroscopic equipment shall not extend beyond the entire visible area of the image...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (b)(2) Further means for limitation (Created page with "''(2) Further means for limitation'' Means shall be provided to permit further limitation of the x-ray field to sizes smaller than the limits of paragraphs CFR 1020.32 Fluor...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (b)(1) Angulation (Created page with "''(1) Angulation'' For fluoroscopic equipment manufactured after February 25, 1978, when the angle between the image receptor and the beam axis of the x-ray beam is variable,...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (a)(2) Measuring compliance (Created page with "''(2) Measuring compliance'' The AKR shall be measured in accordance with paragraph (d) of this section. The AKR due to transmission through the primary barrier combin...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (a)(1) Limitation of useful beam (Created page with "''(1) Limitation of useful beam'' The fluoroscopic imaging assembly shall be provided with a primary protective barrier which intercepts the entire cross section of the useful...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (a) Primary protective barrier (Created page with " Category:fda")
• 07:20, 25 August 2020 Dirkjan talk contribs created page CFR 1020.32 Fluoroscopic equipment (Created page with "The provisions of this section apply to equipment for fluoroscopic imaging or for recording images from the fluoroscopic image receptor, except computed tomography x-ray syste...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Webinar Recording: FDA Design Traceability Requirements for Device Development » The Seapine View (Created page with "=URL= http://blogs.seapine.com/2011/07/webinar-recording-fda-design-traceability-requirements-for-device-development/?utm_source=YouTube&utm_medium=SocialMedia&utm_campaign=So...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Category:Traceability (Created page with "{{category}}")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Category:Regulation (Created page with "{{category}}")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Warning Letter (Created page with "A warning letter is an administrative action typically issued to firms with a Situation I condition identified on their FDA 483 observations. Warni...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Verification Test Plan (Created page with "Verification test plans are created following the master test plan to ensure that each new or modified device is appriopiate for its intended use and approved prior to impleme...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Verification (Created page with "In FDA Design Controls '''''Verification''''' means confirmation by examination and provision of objective evidence that specified requirem...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Track II Inspection (Created page with "A ''Track II Inspection'' is a complete audit of a manufacturers quality system performed by the FDA every four years. Category:fda")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Track I Inspection (Created page with "A ''Track I Inspection'' is a limitted inspection of a manufacturrs quality system performed by the FDA every two years. Routine inspections generally include a review of the...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page Top-Down Inspection (Created page with "A ''Top-Down Inspection'' is the FDA's latest inspection strategy in which inspectors are taught to evaluate the quality system and sampling quality system records. The "top-...")
• 07:20, 25 August 2020 Dirkjan talk contribs created page The Act (Created page with "The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and...")
• 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...")

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