We answer your questions about regulatory affairs!

We love technology, we speak regulation

We are FSQ Experts, a team of engineers versed in regulatory affairs, who will support you in all phases of the development of your medical device. After revising the intended use of your medical device and its classification on the target markets, we will draft together the regulatory and clinical strategy. This will allow us to tailor the requirements of the authorities to your medical device and plan activities ensuring a development compliant with ISO 13485. We will train and enable your development team to create adequate records for your technical file and support its submission to the notified body and other authorities (FDA, NMPA). 

The journey to get market access is full of hurdles. With FSQ Experts on your side, you will never walk alone. At the end of the journey, you will love technology even more and speak regulation fluently. 

Our journey can start at the MedtecLive. Make sure you book a 30 min free consultation slot with our team - send a message to Dr. Filipa Campos-Viola. Slots are limited. Do not miss the chance.  

Available slots: 

• 18/06/2024  

  • 10:00 am 

  • 11:00 am 

  • 14:00 pm 

  • 15:00 pm 
     

• 19/06/2024 

  • 10:00 am 

  • 11:00 am 

  • 14:00 pm 

  • 15:00 pm