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ER-11a - Cecmed

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http://www.fda.gov/cder/dmpq/cgmpregs.html, actualizado en Agosto 29,1996. “Medical Device Exemptions 510(k) and GMP Requirements”, disponible en:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/ “Medical Devices Regulations” (P.C. 1998-783 7 May, 1998), disponible enwww.hcsc.gc.ca/hpbdgps/therapeut/htmleng/schedule.html#1101 Implementation of the Inspection by Accredited Persons Program Under TheMedical Device User Fee and Modernization Act of 2002; AccreditationCriteria: Guidance for Industry, FDA Staff, and Third Parties”, DocumentIssued on: April 28, 2003; disponible en http://www.fda.gov/cdrh/index.html “International Medical Device Regulatory Monitor”, Volumen 12, Number 12,Diciembre 2004, disponible en http://medicaldevicemonitor.com/pdf/sampleissue.pdf http://www.hc-sc.gc.ca/hpfb-degpsa/tpd-dpt/index_devices_quality_e.html,actualizado en 2004/09/09 http://www.hc-sc.gc.ca/hpfb-degpsa/tpd-dpt/cmdcas_q90R0_2000-04-19_e.html, actualizado en 2002/07/30 http://www.fda.gov/cdrh/devadvice/ ISO9001.pdf, actualizado en 06-19-2003. Hoyle, David; Thompson, Jhon : “Del aseguramiento a la Gestión de laCalidad : El Enfoque Basado en Procesos” ISBN 84-8143-240-7. 2002. Martínez Pereira, Dulce María y colectivo de autores: “Programa Reguladorde Equipos Médicos: Experiencias en Cuba” ISBN 959-264-015-7. 2003. Riley, Karen : “Device regulators and industry fear that new internationalstandards will jeopardise quality sistems requirements” Clinica 900, marzo2000. Kimmelman, Ed: “Safer medical devices and quality managemente systems– Requirements for regulatory purposes” ISO Bulletin, noviembre 2003. Allen, Robert : “Revision of ISO 13485 and ISO 13488, the quality systemstandards for medical devices manufacturers: ISO/TC 210 strategy, julio1999. Rodríguez Puente, Ruth; Laserie Crook, Mario; Martínez Llebrez, Vicente:“Gestión, Perfeccionamiento e ISO 9000”, Normalización No. 3, 2000. GHTF Global Harmonization Task Force; http://www.ghtf.org FDA Center for Device and Radiological Health; http://www.fda.gov/cdrh TÜV America Inc.; http://www.tuvamerica.com European Association of Notified Bodies for Medical Devices;http://www.eanbmed.org

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