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Registro Sanitario de Dispositivos Medicos

BySylvie

Celebramos la entrada en vigor del acuerdo para la sustitución del Reporte de Inspección del Establecimiento (EIR) por el ISO13485 !

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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

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…

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SYMA Consulting’s Black Friday

BySylvie

Por sólo una semana, recibe un 30% de descuento en el curso de MDSAP – Medical Device Single Audit Program, en español. Ingresa a www.symaconsulting.com (pestaña e-learning)Ingresando el cupón MDSAP2020 en la página de check-out. O directamente aquí. El descuento termina el 4 de diciembre, pero puedes apartar tu curso y empezarlo de aquí hasta dentro de…

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Brexit – rules for Medical Devices if no deal.

BySylvie

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

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GMED designated under Regulation (EU) 2017/745 on medical devices

BySylvie

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…

Medical Devices Class Ir – Transitional Provisions to MDR
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Medical Devices Class Ir – Transitional Provisions to MDR

BySylvie

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 –…

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