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

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

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 !
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
Medical Device | Regulation

Registro de Dispositivos Sanitarios
BySylvie July 21, 2015April 7, 2020

Latest news: COFEPRIS reviewers will accept proof of ISO 13485 quality system certification instead of Establishment Inspection Reports (EIRs) issued by the FDA.

Read More Registro de Dispositivos Sanitarios
FDA | Medical Device | Regulation

FDA guidance to help current manufacturing limitations due to disruptions caused by the COVID-19 – FDA to temporarily accept changes to devices approved through PMA or HDE.
BySylvie June 2, 2020June 2, 2020

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…

Read More FDA guidance to help current manufacturing limitations due to disruptions caused by the COVID-19 – FDA to temporarily accept changes to devices approved through PMA or HDE.
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”

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