Por 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 […]

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GMED official publication on linkedin: GMED (CE 0459) has been designated as a Notified Body under the Regulation (EU) 2017/745 by the French National Agency for Medicines and Health Products Safety (ANSM). Equipped with this designation since July 8 2020, GMED has mobilized its teams to offer manufacturers with certification services according to the Regulation […]

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For the duration of the public health emergency, FDA does not intend to object to limited modifications to the manufacturing of devices approved through the PMA program or the HDE program, without prior submission of the required PMA or HDE supplement or 30-day notice, where the modification does not create an undue risk in light […]

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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

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https://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

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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 […]

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