It is difficult for digital innovators to know how to interact with regulators, which ones, and when. This course will remove the mystery. It describes how to build a fit-for-purpose regulatory strategy that strengthens your business strategy and differentiates your product in today’s digital health market.
In this course, you will discover why good regulatory strategy is essential to a good business strategy, identify whether digital health products in your portfolio are likely to be regulated and through which mechanisms, learn how to build and implement a regulatory strategy that advances the success of your products, and learn how to build evidence based, high-quality products without paying for expensive consulting services.
The course describes the current and evolving landscape of digital health product regulation by FDA, the components of a fit-for-purpose regulatory strategy and where to begin when building one, and the skills necessary to implement your regulatory strategy and interact with regulators.
Note: This course is licensed from the Digital Medicine Society (DiMe).
Language Availability: English
Suggested Audiences: Care Providers, Developers, Executives, Policymakers, Researchers, Students, Technologists
Organizational Subscription Price: Included as part of an annual subscription to our DiMe: Digital Health Series, which is available for $675 per year/per site as a subscription add-on for government and non-profit organizations; $750 per year/per site as a subscription add-on for for-profit organizations
Independent Learner Price: $149
