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FDA UDI Bevezetés Anyscan SPECT Termékre FDA UDI bevezetés AnyScan SPECT termékre Cser Dániel 2018. október 16. FOUNDATION OF MEDISO 1990 Foundation of MEDISO 1998 MEDISO acquires the Nuclear Medicine department of Gamma Works, the dominant experts and employees of Gamma Works joined MEDISO 2000 Production of the first planar gamma cameras 2006 Production of the first MEDISO preclinical SPECT-CT 2007 Production of the first MEDISO human SPECT-CT 2008 Introduction of AnyScan® the first real triple-modality human SPECT/CT/PET of the world 2014 Beginning the development of nanoScan® multi-modality preclinical system’s PET/MRI module with 3T MRI 2 MEDISO SALES MEDISO SALES CHANNELS . Sales Department at MEDISO . Foreign distributors by contract . MEDISO Subsidiaries abroad Australia, New Zealand: Mediso Pacific Cammeray, NSW Australia Established in 2012 USA: MEDISO USA, Boston, Established in 2012 Germany: MEDISO GmbH, Munster, Established in 2005 GmbH, Munster Poland: MEDISO Polska, Łódz, Established in 1998 3 MEDISO WORLDWIDE DISTRIBUTION More than 1150 SPECT, planar cameras and Hybrid systems and 170 preclinical systems were distributed by MEDISO in 90 countries of the world: Europe Albania - Armenia - Austria - Belarus - Belgium - Bosnia and Herzegovina - Croatia - Czech Republic - Denmark – Finland - France - Germany - Greece - Hungary - Italy - Lithuania - Macedonia - Moldova - Montenegro - Netherlands – Norway - Poland Romania - Russia - Serbia - Slovakia - Spain - Sweden - Switzerland - Turkey - Ukraine - United Kingdom America Argentina - Bolivia - Brazil - Canada - Cuba - Dominican Republic - Mexico - Nicaragua - Paraguay - Peru - Uruguay – USA Africa Algeria - Burkina Faso - Cote d`Ivoire - Democratic Republic of Congo - Ethiopia - Kenya - Libya - Mali - Morocco Mauritius - Niger - Nigeria - Namibia - Senegal - South Africa - Sudan - Tanzania - Tunisia - Zambia – Zimbabwe Asia Bangladesh - China - Hong Kong - India - Indonesia - Iran - Japan - Jordan - Kazakhstan - Kyrgyzstan - Mongolia Nepal - Pakistan Philippines - Saudi Arabia - Singapore - South Korea - Sri Lanka - Syria - Taiwan - Tajikistan - Thailand Uzbekistan Vietnam – Yemen Australia Australia 4 INTRODUCTION OF MEDISO MEDISO IS 100% ENGAGED WITH MEDICAL IMAGING Profile: human-diagnostic and preclinical imaging system - Research Development Manufacturing Sales Services 5 MEDISO PRODUCT GROUPS Multimodality Clinical Systems Multimodality Preclinical Systems AnyScan® Family SPECT-CT-PET nanoScan® Family SPECT-CT, PET- CT, SPECT-CT, PET-MRI, SPECT- CT-PET Gamma Camera MultiScan LFER 150 PET/CT Nucline Family Planar-Dedicated research tool 6 Preclinical Line – nanoScan® Family 7 AnyScan® FAMILY Clinical line AnyScan® triple modality system IMAGING TABLE SPECT CT PET 8 AnyScan® FAMILY Clinical line AnyScan® SC Modular SPECT/CT with 16 or 8 slice diagnostic CT or with 8 slice low dose CT 9 AnyScan® FAMILY Clinical line AnyScan® SPECT/CT/PET Triple Modality System 10 MAIN IMAGING ROOM: AnyScan® SPECT/CT/PET AnyScan® SPECT/CT/PET Triple Modality System installed at ScanoMed, Debrecen 11 AnyScan® FAMILY Clinical line AnyScan S (SPECT) • Large rectangular FOV • Outstanding intrinsic spatial resolution and NEMA parameters • Variable detector angles • Dual line infrared auto body contour • Flexible detector movement • Continuous upgrade paths 12 FDA UDI bevezetés AnyScan SPECT termékre UDI bevezetés főbb lépései 1) US FDA 510(k) engedély 2) US FDA UDI hatósági követelmények tanulmányozása a) Bevezetési határidő definiálás b) Részvétel a GS1 előadásán 3) DI – PI meghatározása 4) Gyártói címkék és kísérő dokumentáció módosítás és bevezetése 5) GUDID regisztráció mint gyártó 6) Termék regisztráció 14 AnyScan SPECT US FDA 510(k) AnyScan SPECT US FDA 510(k) azonosító: k1xxx25 15 US FDA UDI hatósági követelmények • US FDA weboldal nagyon informatív: https://www.fda.gov/medicaldevices/deviceregulationandguidance/uni quedeviceidentification/ • 21 CFR Part 801 – Címkére vonatkozó előírások https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.c fm?CFRPart=801&showFR=1&subpartNode=21:8.0.1.1.2.2 • 2015. június: GS1 UDI workshop • Személyes konzultáció • Határidő a bevezetésre • Class II berendezés • 2016. szeptember 24. 16 DI – PI meghatározása >>> UDI • DI kód = GTIN kód • GS1 a GTIN kód kibocsátónk • AnyScan SPECT DI number >>> 0599xxxxxxxx72 • PI kód • Eddig is használtunk egyedi sorozatszámot a berendezéseinken • >>> SN: AS-604201-S • UDI: (01) 0599xxxxxxxx72 (21)AS-604201-S 17 Gyártói címkék módosítás és bevezetése • Kis darabszámban értékesítünk • Címkék kézi előállítása és nyomtatása • DataMátrix (QR kód alkalmazását preferálta a gyártástechnológia csoportunk, de ez nem lehetséges) 18 UDI a csomagoláson és a csomaglistán xxxxxxx 19 GUDID regisztráció mint gyártó GUDID új fiók létrehozása: DUNS azonosító: 20 GUDID felület 21 Termék DI regisztráció 22 Összegzés Az US FDA weboldalán található információk alapján és a GS1 segítségével gördülékenyen és könnyedén sikerült az UDI bevezetése. 23 AnyScan® EXAMINATION ROOM Thanks for your attention! 24.
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