


Introductory Consultation: Your Regulatory Roadmap
Kick off your project with a focused 30-minute session—an opportunity to chart your device’s path to market and get to know the consultant guiding you. In this brief meeting, we will:
Define Your Scope: Intended use, design status, target markets, or RIMS Implementation needs
Review Key Regulations: FDA, EU MDR/IVDR, plus global requirements, depending upon your project’s scope.
Outline a Tailored Strategy: Submission steps, testing needs, timelines
Meet and Greet: Discuss your consultant’s expertise, background, approach, and collaboration style.
Agree on Next Steps: Deliverables, milestones, and communication
Ready to begin? Select a 30-minute slot below, and let’s turn your vision into a compliant success!
Kick off your project with a focused 30-minute session—an opportunity to chart your device’s path to market and get to know the consultant guiding you. In this brief meeting, we will:
Define Your Scope: Intended use, design status, target markets, or RIMS Implementation needs
Review Key Regulations: FDA, EU MDR/IVDR, plus global requirements, depending upon your project’s scope.
Outline a Tailored Strategy: Submission steps, testing needs, timelines
Meet and Greet: Discuss your consultant’s expertise, background, approach, and collaboration style.
Agree on Next Steps: Deliverables, milestones, and communication
Ready to begin? Select a 30-minute slot below, and let’s turn your vision into a compliant success!