Assisting your Development Team

Many start-up companies do not have the full overview of the regulatory- and quality management requirements for the design and development of a medical device. Those requirements are quite rigid and requires experience and up-to-date knowledge.

Medical Device Consult can guide your company through your design and development project and find the optimal strategic path to CE-mark, device registration and/or approval outside EU.

Design and development services

  • Establishment of design input
  • Fulfillment of General Safety and Performance Requirements from the MDR/IVDR
  • Identify regulatory requirements for your product, based on intended use
  • Establish design verification plans
  • Assist in the establishment of a Risk Management file for your device
  • Selection and qualification of suppliers
  • Liaison with external test institutes for i.e. electrical safety, sterility validation, biocompatibility studies and use- and mechanical testing to be conducted

Establishment and maintenance of Design History File