The regulatory clearance of Medical Devices and IVD require in the USA attention from the early stages of development and funding of a project.
Medidee is a one-stop shop to identify, stabilize and implement a strategy that correctly integrates and business opportunities, regulatory constraints and patient safety.
The usual initial step is the documentation of a regulatory pathway report that incorporates following topics:

  • Identification of regulatory boundaries and their link with proposed intended use
  • Evaluation of possible borderline challenges
  • Classification (I, iI, III), eligibility for 510k, De-Novo, PMA
  • Identification of the applicable guidelines and consensus standards
  • Listing of additional quality constraints such as QSR

Commonly, our startup Clients integrate the regulatory pathway as part of their business plan.


Potentially, we may also help you to navigate one of the essential programs of the FDA such as Breakthrough Device Designation

Our specialized team guides you through the interaction and help you select the right mode of interaction (510k, IDE, PMA) with the FDA. This may include the organization of pre-submission meetings and the setup of the supporting documentation.
Once a regulatory clearance concept is settled, the implementation support may cover following topics:

  • Setup of a documentation architecture
  • Listing and prototyping of required documents
  • Upgrade of the risk management file
  • Organization of the design control and V&V supporting documentation
  • Organization of the process controls, including supplier audits
  • Setup of Clinical Investigations and preparation of Clinical Evaluation Reports
  • Deployment of a Quality Management System compliant with QSR and/or ISO 13485:2016