Good decisions come from wisdom.
Wisdom comes from experience.
Experience comes from bad decisions.
~ Anonymous
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 –…
This is the first time the Mexican Government opens a window for international manufacturers, even if they do not have sanitary registration approvals in Mexico. By Veraque; As published by the UNOPS (United Nations Office for Project Services) the last 25 of August 2020, the Mexican Public Healthcare system signed an agreement to promote an international tender…
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…
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.
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
We are proud to announce the launch of our new e-learning platform: First training published “MDSAP en español”. Recording as we speak: ISO 9001:2015 en español, MDR in english. Contact us for more information!