Regulatory Affairs
Regulatory Pathway Development

The regulatory clearance of Medical Devices and In-Vitro Diagnostic device require 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 patient safety and business objectives.
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 of the product based on the selected regulatory systems (EU, US, China, others)
  • Identification of the applicable laws and standards
  • Listing of additional regulatory constraints such as QMS establishment
  • Identification of the registration sequence for different countries in the world

For Europe, the regulatory pathway review will most probably also integrate an analysis of the impact of the MDR 2017/745 or IVDR 2017/746 deployement currently on-going.
Commonly, our startup Clients integrate the regulatory pathway as part of their business plan.

Implementation & Regulatory Submissions

Once a precise set of regulatory objectives such as CE marking, or USA clearance, has been established, Medidee supports the Client with a crisp and proportional coaching throughout the implementation.

For Europe, we help you select a qualified and hopefully reliable Notified Body and we support the relationship during the whole regulatory process. If necessary, for borderline products, we may have to coach you in front of a National Competent Authorities (NCA) to stabilize a strategy.
For the USA, 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

For Asian countries and Australia, Medidee relies on a network of partners.