E-learning platform
We 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.
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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
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.
ISO14971: Gestión de Riesgos Dispositivos Medicos / Medical Devices Risk Management
BySylvieCurso Abierto – Cupo Limitado – Abril 2015 Mexico DF ! Contacta info@symaconsulting.com
Posición abierta en SYMA Consulting
BySylvieSYMA Consulting está buscando en el DF: Estamos buscando una persona que nos ayude en: -búsqueda de clientes (teléfono, email), y seguimiento, -contactar a consultores potenciales, -procesos administrativos como administración de facturas, y gestión de documentos de trabajo. Ingles necesario. Curriculum: info @ symaconsulting . com
ISO 13485:2015 to be published early 2016
BySylvieReference: http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref2011 A standard for quality management systems specific to the medical devices industry is under review and has just moved a step closer to completion. We take it for granted that devices used in hospitals or medical centres are of high quality and up to scratch, but for manufacturers, the risks of getting it…