Ya está la nueva ISO13485:2016 !!!

BySylvie February 26, 2016April 7, 2020

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

Quality

Can the internal audit be performed by Internal QA Auditor without the need of a technical person for a process/activity audit?
BySylvie November 18, 2011

You can certainly have an internal auditor auditing a process without need of technical support, BUT in some cases your auditors may need support of technical experts. See ISO 19011:2002 Guidelines for Quality Management System auditing 3.10 Definition of Technical Expert: person who provides specific knowledge or expertise to the audit team. We often see…

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CE marking | MDD MDR | Medical Device | Regulation | Uncategorized

GMED designated under Regulation (EU) 2017/745 on medical devices
BySylvie July 15, 2020July 15, 2020

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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Capacitaciones | Medical Device | Regulation

Capacitación de Gestión del Ciclo de vida de los SW Softwares en los dispositivos medicos ISO 62304
BySylvie November 10, 2015April 7, 2020

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…

Read More Capacitación de Gestión del Ciclo de vida de los SW Softwares en los dispositivos medicos ISO 62304
Quality

Gestión de Riesgos ISO 9001 ISO 31000
BySylvie June 4, 2015

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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Medical Device | Quality | Regulation

New Guidance for PMCF – MDR
BySylvie April 26, 2020April 26, 2020

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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CE marking | MDD MDR | Medical Device | Regulation | Uncategorized

Medical Devices Class Ir – Transitional Provisions to MDR
BySylvie November 26, 2020November 26, 2020

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 –…

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