Good decisions come from wisdom.
Wisdom comes from experience.
Experience comes from bad decisions.
~ Anonymous
Ya estamos estudiando el FDIS de la ISO 13485:2016. El borrador se encuentra http://www.iso.org/iso/fr/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59752 La publicación de la versión final está todavía programada en Marzo 2016. Quedense al pendiente de nuestro gap analysis ! Más información info@symaconsulting.com
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 –…
Curso Abierto – Cupo Limitado – Abril 2015 Mexico DF ! Contacta info@symaconsulting.com
Repair vs Rework A general rule applied by many in automotive is: Rework puts the part into the same condition that a first run good part would be. Repair puts the part into functional suitable condition, but it is apparent that some additional work was done. Rework Definition : Correcting of defective, failed, or non-conforming item,…
Watch your thoughts; they become words. Watch your words; they become actions. Watch your actions; they become habits. Watch your habits; they become character. Watch your character; it becomes your destiny.
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…