Registro de Dispositivos Sanitarios
Latest news: COFEPRIS reviewers will accept proof of ISO 13485 quality system certification instead of Establishment Inspection Reports (EIRs) issued by the FDA.
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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…
E-learning platform
BySylvieWe are proud to announce the launch of our new e-learning platform: First training published “MDSAP en español”. Recording as we speak: ISO 9001:2015 en español, MDR in english. Contact us for more information!
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…
FDIS ISO 13485:2016
BySylvieYa estamos estudiando el FDIS de la ISO 13485:2016. El borrador se encuentra http://www.iso.org/iso/fr/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59752 La publicación de la versión final está todavía programada en Marzo 2016. Quedense al pendiente de nuestro gap analysis ! Más información info@symaconsulting.com
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
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.