?url_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Adc&rft.title=Elaboraci%C3%B3n+del+expediente+t%C3%A9cnico+para+el+marcado+CE+de+productos+de+ONCOREC+Diagnostics&rft.creator=Torres+Rodr%C3%ADguez-Arana%2C+Ana&rft.contributor=Ram%C3%ADrez+Castillejo%2C+Mar%C3%ADa+del+Carmen&rft.contributor=Pel%C3%A1ez+Garc%C3%ADa%2C+Miguel+%C3%81ngel&rft.subject=Medicine&rft.description=The+project+presented+in+this+final+degree+work+is+the+compilation+of+a+dossier+with+the+technical+documentation+required+to+acquire+the+CE+mark+through+the+implementation+of+a+quality+system+according+to+the+international+standard+UNE-EN-ISO+13485%3A2018.++The+medical+product+to+be+certified+is+an+in+vitro+diagnostic+device+for+colonic+cancer+relapse.+The+prediction+of+the+disease%E2%80%99s+recurrence+is+made+by+means+of+a+blood+sample+analysis+of+3ml+every+two%2Fthree+months.+The+diagnosis+is+based+on+the+screening+of+circulating+tumour+cells+via+the+characterization+of+several+surface+markers+of+this+type+of+cells.+These+cells+are+found+in+the+bloodstream+in+very+low+proportion+which+are+capable+of+migrating%2C+producing+metastasis%2C+and+therefore+the+relapse+of+the+cancer.++The+current+regulation+on+which+the+product+to+be+certified+is+governed+is+Directive+98%2F79%2FEC+of+the+European+Parliament+and+of+the+Council+of+27+October+1998+on+in+vitro+diagnostic+medical+devices%2C+despite+the+fact+that+in+a+few+years+a+new+directive+will+be+in+place+with+certain+changes+in+the+procedure.++According+to+the+directive+it+is+necessary+that+all+products+comply+with+the+essential+requirements.+These+are+the+obligations+that+the+manufacturer+has+to+assume+in+order+to+minimise+risks%2C+taking+into+account+technical+and+economic+considerations+in+order+to+be+compatible+with+the+protection+of+health+and+safety.++In+order+to+implement+an+effective+quality+management+system%2C+it+is+essential+to+standardize+the+entire+procedure%2C+from+the+moment+the+sample+is+taken+to+the+final+issue+of+the+report+with+the+results.+This+is+done+by+technical+diagnostic+instructions+that+detail+all+the+steps+to+follow+to+make+a+correct+diagnosis.++In+order+to+obtain+the+CE+certification%2C+it+is+necessary+to+draw+up+the+current+CE+Declaration+of+Conformity.+This+is+essential+for+the+quality+management+system%2C+which+are+the+set+of+rules+and+requirements+that+make+it+possible+to+meet+the+quality+standards+that+a+company+requires+to+satisfy+the+requirements+agreed+with+the+customer.++The+QMS+is+carried+out+according+to+the+international+standard+UNE-EN-ISO+13485%3A2018+which+details+the+requirements+that+a+quality+management+system+must+have+for+an+organisation+to+demonstrate+its+capacity+to+provide+health+products.++The+most+important+document+of+the+QMS+is+the+quality+manual%2C+which+is+where+the+objectives+and+quality+standards+of+a+company+are+established.+In+this+document+we+find+the+quality+policies+and+instruments+with+which+the+company+is+committed+to+meet+the+objectives+established.+It+is+based+on+process+management%2C+where+we+can+find+strategic+processes%2C+key+and+support.+Another+of+the+key+documentation+required+in+the+QMS+is+risk+analysis%2C+carried+out+thanks+to+the+international+standard+UNE+EN+ISO+14971%3A2012%2C+supplemented+with+other+risks+that+may+be+associated+with+other+activities+following+the+standard+UNE-EN-ISO+13485%3A2018.+Finally%2C+the+types+of+documentation+contained+in+the+manual+with+their+corresponding+hierarchy+are+detailed.&rft.publisher=E.T.S.+de+Ingenier%C3%83%C2%ADa+Agron%C3%83%C2%B3mica%2C+Alimentaria+y+de+Biosistemas+(UPM)&rft.rights=https%3A%2F%2Fcreativecommons.org%2Flicenses%2Fby-nc-nd%2F3.0%2Fes%2F&rft.date=2019-07&rft.type=info%3Aeu-repo%2Fsemantics%2FbachelorThesis&rft.type=Final+Project&rft.type=PeerReviewed&rft.format=application%2Fpdf&rft.language=spa&rft.rights=info%3Aeu-repo%2Fsemantics%2FopenAccess&rft.identifier=https%3A%2F%2Foa.upm.es%2F57162%2F