Regulatory requirements for medical devices can be very daunting without the correct knowledge and experience. Understanding regulatory requirements for each agency geographically can have its own challenges with a lengthy process.

Our regulatory expertise can help you:

US requirements:

  • Pre-market notification — 510(k)
  • Pre-market approval — PMA
  • Combination product (drug/device) submissions
  • Establishment registration and device listing

European Requirements

  • Technical File, Design Dossier preparation
  • Clinical Evaluations
  • CE Mark facilitation

MDR Requirements

Complete our form below and we will contact you to discuss your specific requirements: