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? EQUIVALENCE cerebral stent claimed equivalence forces different consequences severe no pmcf plan/pmsSafeguarding Public Health<strong>MHRA</strong>Slide 222010©
CLINICAL INVESTIGATION when undertaken/ general principles general principles of need general principles design specific details design ethical considerationsSafeguarding Public Health<strong>MHRA</strong>Slide 232010©
Page 1 and 2: Safeguarding public healthCLINICAL
Page 3 and 4: NHS NEGLIGANCE2009/10£827,367,000S
Page 5 and 6: NUMBERS/CLAIM VALUESafeguarding Pub
Page 7 and 8: EU REGULATORY SYSTEMarticle 20inves
Page 9 and 10: CLINICAL DATA“……..as a genera
Page 11 and 12: ESSENTIALREQUIREMENTS“…..demons
Page 13 and 14: GHTF DOCUMENTS clinical evidence: d
Page 15 and 16: SOURCES OF DATA literature searchin
Page 17 and 18: APPRAISAL suitability of data type
Page 19 and 20: STAGES EVALUATIONidentify clinical
Page 21: ? EQUIVALENCE atrial appendage plug
Page 25 and 26: ISSUES pre-market testing inadequat
Page 27 and 28: ENDPOINTS clinical investigation re
Page 29 and 30: PMCFpost-market clinical follow-up
Page 31 and 32: SUMMARY the requirements Directives

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