MHRA powerpoint template - TOPRA

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POST MARKETSURVEILLANCE none, other than customer complaints inappropriate/inadequate strategies clinical frustration! patient safetySafeguarding Public Health<strong>MHRA</strong> IVC filter increased claims retrievability complete change clinical practice increased morbiditySlide 302010©
SUMMARY the requirements Directives are fine the guidance documents are comprehensive…..we just all need to read,interpret and implement better…..Safeguarding Public Health<strong>MHRA</strong>Slide 312010©
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 and 22: ? EQUIVALENCE atrial appendage plug
Page 23 and 24: CLINICAL INVESTIGATION when underta
Page 25 and 26: ISSUES pre-market testing inadequat
Page 27 and 28: ENDPOINTS clinical investigation re
Page 29: PMCFpost-market clinical follow-up

MHRA powerpoint template - TOPRA

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