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 – Harmonized Standards MDD – New Listing
BySylvie July 2, 2020July 2, 2020

In 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.

Read More Medical Devices – Harmonized Standards MDD – New Listing
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

What are some best practices for Root Cause Analysis and Preventive Action?
BySylvie April 17, 2012April 17, 2012

Our recommendation in terms of effective corrective and preventive action plans is to be very systematic in every step…. 1) First of a all VERY good definition of the defect…. If not defined correctly the action plan will not be effective. 2) Define corrections and containment actions. Make sure everybody understands the difference between those…

Read More What are some best practices for Root Cause Analysis and Preventive Action?
Quality

Comparación ISO 9001:2008 vs ISO 9001:2015
BySylvie November 5, 2015April 7, 2020

Nuestros consultores han trabajado en prepararles un análisis de las diferencias entre las 2 normas. Para descargarla: entren a http://www.symaconsulting.com/iso-90012015/

Read More Comparación ISO 9001:2008 vs ISO 9001:2015
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 | 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

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