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Dispositivos Médicos / Medical Devices
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Dispositivos Médicos

Os dispositivos médicos são instrumentos importantes de saúde que seguem uma regulamentação muito rígida. Além disso, os investidores esperam resultados rápidos e prova de desempenho/segurança/qualidade do produto ainda mais rápido. É por isso que você precisa de um parceiro como CBIOS com recursos e experiência.

 

Os nossos consultores têm uma experiência considerável na elaboração de estratégias de regulamentação, nos processos de pré -submissão aos organismos notificados e às autoridades competentes bem como nos processos de vigilância pós-mercado, onde o nosso principal objetivo é manter a vantagem competitiva de um negócio desafiante e de acordo com o ambiente regulatório.

  


  

Medical Devices

Medical devices are important health instruments that follows a stricter regulation. Furthermore, investors expect results fast, and proof of efficacy/safety/product quality even faster. This is why you need a partner with CBIOS’s fully integrated global resources and medical device experience to guide you.

 

Our consultants have considerable experience in developing regulatory strategies, in the pre-submission processes to the notified bodies and to the competent authorities as well as in post-market surveillance processes, where our main goal is to maintain the competitive advantage of a challenging business and according to the regulatory environment.