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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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Similar Posts
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…
Nice words…
BySylvieGood Decision Good decisions come from wisdom. Wisdom comes from experience. Experience comes from bad decisions. ~ Anonymous
ISO14971: Gestión de Riesgos Dispositivos Medicos / Medical Devices Risk Management
BySylvieCurso Abierto – Cupo Limitado – Abril 2015 Mexico DF ! Contacta 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
Registro Sanitario de Dispositivos Medicos
BySylvieCelebramos la entrada en vigor del acuerdo para la sustitución del Reporte de Inspección del Establecimiento (EIR) por el ISO13485 !
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.