Inspection. Inspection consists of visual examination of the abdomen with note made of the shape of the abdomen, skin abnormalities, abdominal masses, and the movement of the abdominal wall with respiration. Find 28 ways to say INSPECTION, along with antonyms, related words, and example sentences at Thesaurus.com, the world's most trusted free thesaurus. Routine. 2. In regards to the inspection of medical devices, there are two standards, ISO 13845 and FDA 21 CFR Part 820. An examination or investigation; the right to see and duplicate documents, enter land, or make other such examinations for the purpose of gathering evidence. The act of inspecting. inspection The act by a regulatory authority of conducting an official review of documents, facilities, records and any other resources that the authority deems to be related to the clinical trial, which may be located at the site of the trial, at the sponsor's and/or contract research organisation's (CRO's) facilities, or at other establishments deemed appropriate by the regulatory authority. Guide to Inspections of Medical Device Manufacturers. NFPA 99 2012 Edition 5.1.14.2.2.2* Inspection Schedules. Download Free Sample Medical Device FAI form (Excel file with unlocked sheets and cells). The possible outcomes of an inspection are that the inspector will either recommend for or against FDA approval. This information should not be considered complete, up to date, and is not intended to be used in place of a visit, consultation, or advice of a legal, medical… The routine physical, also known as general medical examination, periodic health evaluation, annual physical, comprehensive medical exam, general health check, preventive health examination, medical check-up, or simply medical, is a physical examination performed on an asymptomatic patient for medical screening purposes. Routine inspections. Scheduled inspections for equipment and procedures shall be established through the risk assessment of the facility and developed with consideration of the original equipment manufacturer recommendations and other recommendations as required by the authority Abnormalities detected on inspection provide clues to intra-abdominal pathology; these are further investigated with auscultation and palpation. ... have seldom been submitted for medical inspection by even the fairest patient desiring a prescription of unfamiliar scenes. inspection synonyms, inspection pronunciation, inspection translation, English dictionary definition of inspection. Providing Industry Education and Assistance – CDRH Resources Federal Food, Drug, and Cosmetic Act 21 Code of Federal Regulations (800-1299) Guidance Documents (can be accessed from www.FDA.gov website under Medical devices CDRH Device Advice Quality Systems Manual: A Small Entity Compliance Guide on- line Compliance Policy Guides Quality System Inspection Techniques (QSIT) These are the inspections mandated by law to be expected every two years for manufacturers of Class II or Class III medical devices. inspecting my medical gas systems? Define inspection. In similar to the AS9102, a ballooned drawing and an inspection form are required to verify that the part has been manufactured correctly. Definition. The inspection should ascertain what files are maintained that meet the definition of a complaint (21 CFR 820.198). All content on this website, including dictionary, thesaurus, literature, geography, and other reference data is for informational purposes only. 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