¿Cómo trabajar con nosotros?

Acceso al mercado chino de Medtec

How to work with us for your success in medtec sector

1. Elija y utilice su primer contacto.

  • We meet online and exchange

  • Reunión presencial

    A personal meet is always worthy

  • Classic and solution tailored

We believe that we should firstly know you personally, learn your product and your company. Then we talk about your inquiry in details. Use our 45 min free meeting and decide whether we meet online or offline. After understanding the need and a matched project plan, success is following.



2. Seleccionen la forma de trabajar juntos.


  • typical product registration

  • Externalización de conocimientos especializados

    Choose any topics for an evaluation

  • Nuestro experto forma parte de su equipo.

  • Predicable and cost-saving

  • También podemos reunirnos periódicamente a precio fijo.

  • Hasta que estés satisfecho

En función de la demanda de los clientes, estamos considerando la opción de enviar a nuestro experto en artritis reumatoide para liderar un grupo sin experiencia y dejar que el equipo se encargue de elaborar internamente un expediente completo sobre China. Si la empresa carece de los recursos necesarios, podemos adaptarnos a las necesidades más urgentes (coordinación de pruebas de tipificación, redacción de evaluaciones clínicas, edición de informes posteriores a la comercialización).


With us you will save budget with our efficient way to work. We could charge only if the allocation is used in an hourly base or we meet at jour fixe to solve the problem at an annual flat rate. The unique payment of “Donate upon satisfaction” is a rising star. You decide it how much to pay after getting our expertise opinion or approved certificate.



3. Defina los detalles del servicio.


  • Procedure with Chinese elements

  • Control de primas

    Controlar los asuntos relacionados con China no solo ahorra dinero y tiempo.

  • tercera voz experta

    Mereces elegir la mejor oferta y opinión.

  • Apoyamos con análisis de brechas y acciones

  • timeline of registration, prove of documents and competitor analysis

  • We try to improve Chinese partners by audit with your requirements

  • Inspección en el extranjero

    Le explicamos al auditor su proceso

  • Gestión del etiquetado

    Either IFU, Label or UDI, with us is garantee

You have your own process from design of device, verification and validation, registration to distribution of device. Oft it must be revised due to changed and additional different Chinese requirements. We are supporting with our best practice.


Controlling is rarely at regulatory affairs, however is important as a long term stabiliizer. Everybody is happy if the Chinese registration or Chinese inspection is behind. The trouble is turning up till next change registration, next revision of instruction for use or if another colleague takes the task over. The old folders and documents are badly to recognize and understand. We have a critical and useful view to provide some suggestions to optimize the registration dossier, communication with representative, distributor, authority and users.


A menudo, te encuentras con una oferta, un dictamen pericial o una carta de deficiencias con la que no puedes empezar. Pídenos una opinión imparcial.


The soft skills behind regulatory affairs are interdisciplinary and intercultural. With these weapons you can talk with every R&D head, CEO, local partner as representative, reviewer and inspector form authority. We know western and pan-Asian mentality, regulatory difference and whole life cycle of medical device. Use our expertise as bridge to pass overseas inspection, to submit post market reports, to monitor and improve the quality of Chinese partners.

Lea la capacitación sobre Lean en Asuntos Regulatorios.

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