Registro Sanitario de Dispositivos Medicos
Celebramos la entrada en vigor del acuerdo para la sustitución del Reporte de Inspección del Establecimiento (EIR) por el ISO13485 !
Celebramos la entrada en vigor del acuerdo para la sustitución del Reporte de Inspección del Establecimiento (EIR) por el ISO13485 !
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!
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 –…
https://www.gov.uk/government/publications/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal/further-guidance-note-on-the-regulation-of-medicines-medical-devices-and-clinical-trials-if-theres-no-brexit-deal?utm_medium=social&utm_source=linkedin.company&utm_campaign=postfity&utm_content=postfityffbe0
Medical Devices Regulation postponed by a year in the EU. “With patient health and safety as a guiding principle, the Commission adopted a proposal on 3 April 2020 to postpone the application date of the Medical Devices Regulation (MDR) for one year. The goal is to have the Parliament and Council adopt the proposal by…
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…
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…