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

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

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…

Read More Can the internal audit be performed by Internal QA Auditor without the need of a technical person for a process/activity audit?
Quality

Root Cause Analysis: nice article !
BySylvie April 18, 2011

Hey, Ms. Auditee: Did Mickey Mouse Do Your Root Cause Analysis?: http://www.qualitydigest.com/inside/quality-insider-article/hello-mr-auditee-did-mickey-mouse-do-your-root-cause-analysis.html

Read More Root Cause Analysis: nice article !
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 –…

Read More Medical Devices Class Ir – Transitional Provisions to MDR
Quality

ISO 9001:2008, Clause 8.3 “Control of nonconforming product”
BySylvie June 4, 2015June 4, 2015

When one or more characteristics of a product fail to meet specified requirements, it is referred to as a nonconforming product. When a product deviates from specified product requirements, it fails to conform. Nonconforming products must be identified and controlled to prevent unintended use or delivery. Nonconforming product is defined as product that does not…

Read More ISO 9001:2008, Clause 8.3 “Control of nonconforming product”
Medical Device | Quality | Regulation

Comercialización de DM esterilizados en ETO / recién nacidos y prematuros
BySylvie October 13, 2015April 7, 2020

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

Read More Comercialización de DM esterilizados en ETO / recién nacidos y prematuros

Similar Posts

Leave a Reply Cancel reply