Regulatory Support

A guide through certification and market approval

Defined quality standards and product certification are fundamental for a medical device to reach the market. Here at Oculox we know the complexity and investment required to face regulatory affairs processes. We have the experience to take care of all the steps for a successful development of your medical device.
 
With help of our network of experts, we will guide you through:

  • preparation of a regulatory plan
  • risk management analysis (ISO 14971)
  • definition of the usability engineering process (IEC 62366)
  • realization of a complete technical dossier (IEC 62304)
  • collection of regulatory requirements for medical devices (IEC 60601-x-xx, IEC 60825-1)
We provide you support for: 

  • project management (ISO 13485)
  • risk analysis and mitigation
  • verification and validation processes
  • formative and summative evaluation sessions

Start getting your medical device developed today

A guide through certification and market approval

Defined quality standards and product certification are increasingly fundamental for a medical device to reach the market. Here at Oculox we know the complexity and investment required to face regulatory affairs processes. The accumulated experience allows us to take care of all the steps for a successful development of your medical device.
 
With help of our network of experts, we will guide you through:
  • preparing regulatory plan
  • addressing risk management (ISO 14971)
  • defining usability engineering process (IEC 62366)
  • writing full technical dossier (IEC 62304)
  • collecting regulatory requirements for medical device (IEC 60601-x-xx, IEC 60825-1)
We provide you support for: 
  • project management (ISO 13485)
  • risk analysis and mitigation
  • verification and validation processes
  • formative and summative evaluation sessions