US Product Submissions

CMD Consulting can help companies located in Scandinavia and Europe in understanding and responding to US Medical Devices regulatory requirements, especially with respect to:

  • reviewing draft submission documentation such as Pre-Market Notification 510(k) clearance and Investigational Device Except (IDE) applications 
  • establishing sufficient documentation to meet FDA Software Validation requirements 
  • establishing sufficient documentation to meet FDA requirements for complex devices (Combination products) and sterile devices 
  • assisting in the development of labelling, including user manuals, that meets US regulatory and customer requirements 
  • for selected projects, directly translating or arranging for the translation of documentation and labelling required for the submission 
  • obtaining applicable guidance documents and standards