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RAPS Study with correct Answers
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RAPS Study with correct Answers
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RAPS Study with correct AnswersConflict iiiiof iiiiInterest iiii- iiiiAnswers iiii-Situation iiiiin iiiiwhich iiiithe iiiiconcerns iiiior iiiiaims iiiiof
iiiitwo iiiidifferent iiiiparties iiiiare iiiiincompattable
Corrections iiiiand iiiiRemovals iiii(C&R) iiiiRule iiii- iiiiAnswers iiii-The iiiirule iiiithat iiiiany iiiifield
iiiicorrections iiiito, iiiior iiiiremoval iiiiof, iiiidevices iiiion iiiithe iiiimarket iiiidue iiiito iiiia iiiipotential
iiiirisk iiiito iiiihealth iiiimust iiiibe iiiireported iiiito iiiiFDA
Refuse iiiito iiiiAccept iiii(RTA) iiii-- iiii5 iiii- iiiiAnswers iiii-Letter iiiiFDA iiiisends iiiito iiiia iiiidevice
iiiisponsor iiiisubmitting iiiia iiiiPMA iiiithat iiiifails iiii
1. iiiito iiiiadhere iiiito iiiiFDA iiiiformat iiiireccomendations
2. iiiifails iiiito iiiifile iiiian iiiie-copy iiiiof iiiithe iiiisubmission
3. iiiisubmits iiiithe iiiiwrong iiiiPMA iiiitype
4. iiiifails iiiito iiiiidentify iiiiappropritate iiiiFDA iiiiguidace
5. iiiiand iiii/or iiiifails iiiito iiiisubmit iiiidevice iiiitest iiiidata
Class iiiiIIb iiiiDevices iiii- iiiiAnswers iiii-device iiiiclass iiiifor iiiidevices iiiithat iiiiare iiiislightly
iiiimore iiiicomplex iiiidevices iiiithan iiiiIIa iiiidevices iiiiand iiiiare iiiioften iiiiinstalled iiiiwithin iiiithe
iiiibody iiiifor iiiimore iiiithan iiii30 iiiidays. iiiiClass iiiiIIb iiiirefers iiiito iiiimost iiiisurgically iiiiinvasive
iiiior iiiiactive iiiidevices iiiiwhich iiiiare iiiipartially iiiior iiiientirely iiiiimplanted iiiiinto iiiithe iiiibody.
iiiiThis iiiiclass iiiimay iiiialso iiiimodify iiiithe iiiicomposition iiiiof iiiibody iiiifluids
CE iiiiMark iiii- iiiiAnswers iiii-European iiiiConfirmity iiiimark. iiiimandatory iiiiEuropean iiiimark
iiiifor iiiiproducts iiiifalling iiiiunder iiiione iiiiof iiiithe iiiinew iiiiapproach iiiidirectives iiii(including
iiiimedical iiiidevices) iiiito iiiiindicate iiiiconformity iiiiwith iiiiessential iiiihealth iiiiand iiiisafety
iiiirequirements
Device iiiiSubcatagory iiii- iiiiAnswers iiii-a iiiiset iiiiof iiiidevices iiiihaving iiiicommon iiiiareas iiiiof
iiiiinteded iiiiuse iiiior iiiicommon iiiitechnology
Device iiii- iiiiAnswers iiii-Any iiiihealthcare iiiiproduct iiiithat iiiidoes iiiinot iiiiachieve iiiiits
iiiiprincipal iiiiinteded iiiipurposes iiiiby iiiichemical iiiiaction iiiiin iiiior iiiion iiiithe iiiibody iiiior iiiiby
iiiibeing iiiimetabolized. iiiia iiiidevice iiiiis iiiiinteded iiiifor iiiiuse iiiiin iiiithe iiiidiagnosis iiiiof
iiiidiseasse iiiior iiiiother iiiiconidtions, iiiior iiiiin iiiithe iiiicure, iiiimitigation, iiiitreatment, iiiior
iiiiprevention iiiiof iiiidisease
In iiiiVitro iiiiMedical iiiiDevice iiii(IVMD), iiiiIVD iiii- iiiiAnswers iiii-any iiiimedical iiiidevice iiiiwhich
iiiiis iiiia iiiireagent, iiiireagent iiiiproduct, iiiicalibrator, iiiicontrol iiiimaterial iiiikit, iiiiinstrumet,
iiiiappratus, iiiiequipment, iiiior iiiisystem, iiiiwhether iiiiused iiiialone iiiior iiiiin iiiicombination,
iiiiintended iiiiby iiiithe iiiimanufacturer iiiito iiiibe iiiiused iiiiin iiiivitro iiiifor iiiithe iiiiexamination iiiiof
iiiispecimens
,Intellectual iiiiproperty iiiirights iiii(IPRs) iiii- iiiiAnswers iiii-the iiiiarea iiiiof iiiilaw iiiithat iiiiregulates
iiiithe iiiiownership iiiiand iiiiuse iiiiof iiiicreative iiiiworks, iiiiincluding iiiipatent, iiiicopyright, iiiiand
iiiitrademark iiiilaw. iiiiIntellectual iiiiproperty iiiirights iiiihave iiiibeen iiiideveloped iiiito iiiiprotect
iiiicreative iiiipeople iiiiwho iiiihave iiiidisclosed iiiitheir iiiiwork iiiifor iiiithe iiiibeneift iiiiof
iiiihumankind iiiifrom iiiihaving iiiiit iiiicopied iiiior iiiiimitated iiiiwithout iiiitheir iiiiconsent
Invasive iiiiDevice iiii- iiiiAnswers iiii-a iiiidevice, iiiiwhich, iiiiin iiiiwhole iiiior iiiiin iiiipart, iiiipenetrates
iiiiinside iiiithe iiiibody, iiiienters iiiithrough iiiia iiiibody iiiiorifce, iiiior iiiithrough iiiithe iiiisurface iiiiof
iiiithe iiiibody
Memorandum iiiiof iiiiUnderstanding iiii(MOU) iiii- iiiiAnswers iiii-agreement iiiibetween
iiiiregulatory iiiiauthorities iiiiallowing iiiimutual iiiirecognition iiiiof iiiiinspections
Generic iiiiDevice iiiiGroup iiii- iiiiAnswers iiii-a iiiiset iiiiof iiiidevices iiiihaving iiiithe iiiisame iiiior
iiiisimilar iiiiintended iiiiuses iiiior iiiicommonality iiiiof iiiitechnology iiiiallowing iiiithem iiiito iiiibe
iiiiclassified iiiiin iiiia iiiigeneric iiiimanner iiiinot iiiireflecting iiiispecific iiiicharacteristics
Universal iiiiMedical iiiiDevice iiiiNomenclature iiiiSystem iiii(UMDNS) iiii- iiiiAnswers iiii-
standard iiiiinternational iiiinomenclature iiiiand iiiicomputer iiiicoding iiiisystem iiiifor iiiimedical
iiiidevices
Consumer iiiiPrice iiiiIndex iiii(CPI) iiii- iiiiAnswers iiii-a iiiistatisical iiiitime-series iiiimeasure iiiiof
iiiia iiiiweighted iiiiaverage iiiiof iiiiprices iiiiof iiiia iiiispecified iiiiset iiiiof iiiigoods iiiiand iiiiservices
iiiipurchased iiiiby iiiiconsumers. iiiiit iiiitracks iiiithe iiiiprices iiiiof iiiispecified iiiiconsumer iiiigoods
iiiiand iiiiservices, iiiiproviding iiiia iiiimeasure iiiiof iiiiinflation
Companion iiiiDiagnositc iiii(CDx/CoDx) iiii- iiiiAnswers iiii-an iiiiin iiiivitro iiiidiagnostic iiiidevice
iiiior iiiiimaging iiiitool iiiithat iiiiprovides iiiiinformation iiiithat iiiiis iiiiessential iiiifor iiiithe iiiisafe iiiiand
iiiieffective iiiiuse iiiiof iiiia iiiicorresponding iiiitherapeutic iiiiproduct
Class iiiiII iiiidevice iiii- iiiiAnswers iiii-Requires iiiigeneral iiiiand iiiispecial iiiicontrols iiiito iiiiensure
iiiisafety iiiiand iiiieffectiveness. iiiiSpecial iiiicontrols iiiimay iiiiinclude iiiimandatory
iiiiperformance iiiistandards, iiiipatient iiiiregistries iiiifor iiiiimplantable iiiidevices iiiiand iiiipost
iiiimarket iiiisurveillance.
Requires iiii510(k) iiiiunless iiiiexempted; iiiimay iiiirequire iiiiclinical iiiitrials
iiiidivided iiiiinto iiiia iiiiand iiiib
Center iiiifor iiiiDevices iiiiand iiiiRadiological iiiihealth iiii(CDRH) iiii- iiiiAnswers iiii-US iiiiFDA
iiiicenter iiiiresponsible iiiifor iiiiregulating iiiifirms iiiithat iiiimanufacture, iiiirepackage, iiiire-label
iiiiand/or iiiiimport iiiimedical iiiidevices iiiisold iiiiin iiiithe iiiiUS, iiiiand iiiiradiation-emitting
iiiielectronic iiiiproducts iiii(medical iiiiand iiiinon-medical) iiiisuch iiiias iiiilasers, iiiiX-ray
iiiisystems, iiiimicrowave iiiiovens iiiiand iiiicolor iiiitelevisions
, Banned iiiidevice iiii- iiiiAnswers iiii-a iiiidevice iiiithat iiiipresents iiiia iiiisubstantial iiiideception,
iiiiunreasonable iiiirisk iiiiof iiiiinjury iiiior iiiiillness, iiiior iiiiunreasonable iiiidirect iiiiand iiiisubstantial
iiiidanger iiiito iiiithe iiiipublic's iiiihealth
Letter iiiiof iiiiAuthorization iiii(LOA) iiii- iiiiAnswers iiii-a iiiiletter iiiifrom iiiithe iiiiholder iiiiof iiiia iiiidrug
iiiimaster iiiifile iiii(DMF) iiiito iiiiFDA, iiiiauthorizing iiiianother iiiiparty iiiito iiiireference iiiithe iiiiDMF
Labeling iiii- iiiiAnswers iiii-All iiiiwritten, iiiiprinted, iiiior iiiigraphic iiiimatter iiiiaccompanying iiiian
iiiiarticle iiiiat iiiiany iiiitime iiiiwhile iiiisuch iiiiarticle iiiiis iiiiin iiiiinterstate iiiicommerce iiiior iiiiheld iiiifor
iiiisale iiiiafter iiiishipment iiiiin iiiiinterstate iiiicommerce. iiiiincludes iiiiuser iiiimanuals,
iiiibrochure, iiiiadvertsing, iiiietc.,
Field iiiisafety iiiicorrective iiiiaction iiii(FSCA) iiii- iiiiAnswers iiii-An iiiiaction iiiitaken iiiiby iiiia
iiiimanufcturer iiiito iiiireduce iiiia iiiirisk iiiiof iiiideath iiiior iiiiserious iiiihealth iiiideterioration
iiiiassoicated iiiiwith iiiithe iiiiuse iiiiof iiiia iiiimedical iiiidevice. iiiiIn iiiiassessing iiiithe iiiineed iiiiof
iiiithis, iiiithe iiiimanufacturer iiiimay iiiiuse iiiithe iiiimethodology iiiidescribed iiiiin iiiiIsO iiii14971
European iiiiCommunity iiii(EC) iiii- iiiiAnswers iiii-the iiiicollective iiiibody iiiiformerly iiiinamed
iiiiEuropean iiiiEconomic iiiiCommunity iiii(ECC).
Good iiiiEngineering iiiiPractice iiii(GEP) iiii- iiiiAnswers iiii-proven iiiiand iiiiaccepted
iiiiengineering iiiimethods, iiiiprocedures, iiiiand iiiipractices iiiithat iiiiprovide iiiiappropriate,
iiiicost-effective, iiiiand iiiiwell-documented iiiisolutions iiiito iiiimeet iiiiuser iiiirequirements iiiiand
iiiicompliance iiiiwith iiiiapplicable iiiiregulations
Good iiiivigilance iiiipractice iiii(GVP) iiii- iiiiAnswers iiii-EU- iiiiThe iiiicontinuous iiiiimprovement
iiiiin iiiimedical iiiidrug/device iiiisafety iiii(helps iiiibuild iiiipublic iiiitrust)
Global iiiiHarmonization iiiiWorking iiiiGroup iiii(GHWP) iiii- iiiiAnswers iiii-nonprofit
iiiiorganization iiiiwhose iiiimission iiiiis iiiito iiiistudy iiiiand iiiireccomend iiiiways iiiito iiiiharmonize
iiiimedical iiiidevice iiiiregulations iiiiin iiiithe iiiiasia iiiiand iiiiother iiiiemerging iiiiregions iiiiand iiiito
iiiiwork iiiiin iiiicoordination iiiiwith iiiiIMDRF, iiiiAPEC, iiiiand iiiiother iiiirelated iiiiinternational
iiiiorganizations. iiiiFormerly iiiiknown iiiias iiiiAsian iiiiHarmonization iiiiWorking iiiiParty
Special iiii510(K) iiii- iiiiwhen iiiito iiiiuse, iiiiprocessing iiiitime, iiiihow iiiicompares iiiito iiiitraditional
iiii510(k) iiii- iiiiAnswers iiii-The iiiiprogram iiiiis iiiispecifically iiiifor iiiimanufacturers iiiiseeking
iiiimarket iiiiclearance iiiiwhen iiiimaking iiiimodifications iiiito iiiitheir iiiiown iiiiexisting,
iiiipreviously-cleared iiiimedical iiiidevices.
Changes iiiicould iiiibe: iiiicertain iiiidesign iiiiand iiiilabeling iiiichanges, iiiiincluding iiiichanges
iiiito iiiithe iiiiindications iiiifor iiiiuse. iiiiUsually iiiithe iiiichange iiiieither iiiidoesn't iiiirequire
iiiiperformance iiiidata iiiior iiiithe iiiiperformance iiiidata iiiiis iiiineeded, iiiiit iiiican iiiibe iiiifound
iiiithrough iiiiestablished iiiimethods. iiii
Processing iiiitime- iiii30 iiiidays. iiiiSimillar-ish iiiito iiiitraditional iiii510(k) iiiiexcept iiiipredicate
iiiiis iiiiown iiiidevice iiiibecause iiiibut iiiithis iiiiallows iiiiyou iiiito iiiicompare iiiito iiiistandards
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