Registro Sanitario de Dispositivos Medicos
Celebramos la entrada en vigor del acuerdo para la sustitución del Reporte de Inspección del Establecimiento (EIR) por el ISO13485 !
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New Guidance for PMCF – MDR
BySylvie4 new guidances related to Clinical investigation and evaluation were recently published on the commission website including a template for the PMCF, the guidance on sufficient clinical evidence for legacy devices and a guidance for equivalent devices ! https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
Brexit – rules for Medical Devices if no deal.
BySylviehttps://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal?utm_medium=social&utm_source=linkedin.company&utm_campaign=postfity&utm_content=postfityffbe0
Capacitación de Gestión del Ciclo de vida de los SW Softwares en los dispositivos medicos ISO 62304
BySylvieEn diciembre 2015, un business partner de SYMA va a ofrecer un curso de 2 dias en ISO 62304 en Washington DC. Información en info@symaconsulting.com 2 days training course on Medical Device Software Lifecycle Processes. Date: December 14th and 15th, 2015 Special Early Bird tickets are only available until November 13 th. Location: Washington DC…
Medical Devices – Harmonized Standards MDD – New Listing
BySylvieIn March this year, a new list of harmonized standard was published, see the new list in this link: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/ You need to download the files now in order to see the list.
SYMA Consulting’s Black Friday
BySylviePor sólo una semana, recibe un 30% de descuento en el curso de MDSAP – Medical Device Single Audit Program, en español. Ingresa a www.symaconsulting.com (pestaña e-learning)Ingresando el cupón MDSAP2020 en la página de check-out. O directamente aquí. El descuento termina el 4 de diciembre, pero puedes apartar tu curso y empezarlo de aquí hasta dentro de…
Medical Devices Regulation MDR Postponed.
BySylvieMedical Devices Regulation postponed by a year in the EU. “With patient health and safety as a guiding principle, the Commission adopted a proposal on 3 April 2020 to postpone the application date of the Medical Devices Regulation (MDR) for one year. The goal is to have the Parliament and Council adopt the proposal by…