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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While the world is fighting against the virus, company fighting about economical crisis, certificates are still expiring and notified bodies and auditing organizations have to look for new ways to work. Our partner GMED NA, has put in place exceptional provisions for certification audits impacted by this health crisis. Depending on the type of audit, […]

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Ya 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

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Reference: 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 […]

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La ISO 9001, en su próxima versión del 2015, nos exigirá una gestión de riesgos. Una de las metodologías a aplicar puede ser ISO 31000. Se trata de una norma que establece los principios para diseñar, implementar y mantener una gestión de riesgos sistemática y transparente de cualquier forma de riesgo y en cualquier contexto. […]

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