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Registro de Dispositivos Sanitarios

BySylvie

Latest news: COFEPRIS reviewers will accept proof of ISO 13485 quality system certification instead of Establishment Inspection Reports (EIRs) issued by the FDA.

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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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Medical Devices Regulation MDR Postponed.

BySylvie

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…

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