It is not easy to follow how and when to apply the new future MDR, a big pressure has been set on the class I reusable medical devices manufacturer to be ready to transition, yes but by when? Well back in July, the rules have changed again but are offering a longer transition period –…
Ya se publico la nueva norma ISO 13485:2016 !!! http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59752 Pregunta por nuestro curso ! info@symaconsulting.com
Cambios en Francia para la comercialización de dispositivos medicos estériles con uso para bebes, recién nacidos y prematuros. Con aplicación mandatoria en los 6 próximos meses ! Para más información info@symaconsulting.com y: ansm – ETO
En 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…
4 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
Celebramos la entrada en vigor del acuerdo para la sustitución del Reporte de Inspección del Establecimiento (EIR) por el ISO13485 !