Path to Market

A guide for companies on getting their first regulated product to market

Path to Market

Lesson 1: Welcome

About this course

This course is a guide on getting your first regulated product on the market.

In this course we will review the various phases involved in product development:

  • Phase 1: Product Plan and Strategy
  • Phase 2: Product Design and Development
  • Phase 3: Final V&V and Submission
  • Phase 4: Commercialization

At the end of the course, complete the course quiz.


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() lessons in this course

Phase 1: Product Plan and Strategy
Phase 2: Product Design and Development
Phase 3: Final V&V and Submission
Phase 4: Commercialization


Welcome to the Path to Market Course!

This guide contains information and recommendations for medical device and software as a medical device (SaMD) companies to get their product to market.  The process is divided into 4 phases, and the guide outlines activities and deliverables for each phase. Ultimately, the specifics of each company's path to market will vary based on their unique products and circumstances.

On the right you'll see the sections we'll cover in this course and you can download the course slides.

Let's get started!

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