I wish this course existed when we were getting started 10 years ago!
Course Overview
It’s difficult for digital innovators to know how to interact with regulators, which ones, and when. This course will remove the mystery. Learn how to build a fit-for-purpose regulatory strategy that strengthens your business strategy and differentiates your product in today’s digital health market.
Learning Outcomes
Identify whether digital health products in your portfolio are likely to be regulated and through which mechanisms. Build and implement a regulatory strategy that advances the success of your products. Build evidence based, high-quality products without paying for expensive consulting services.
Discover why good regulatory strategy is essential to a good business strategy.
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Today’s Regulatory Landscape
What to know about the current and evolving landscape of digital health product regulation by FDA.
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Elements of a Robust Strategy
Details on the components of a fit-for-purpose regulatory strategy and where to begin when building one.
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Ensuring Successful Implementation
Obtain the skills necessary to implement your regulatory strategy and interact with regulators.
Learning from industry experts throughout this course was very impactful. The course helped me appreciate the challenges and successes of digital innovation using real world cases and provided an understanding of available toolkits to thrive in this volatile and uncertain landscape. I really appreciated the parts of the course that emphasized the need for partnership in development at every stage and the quality improvement tips provided.
The course provided a simple and efficient approach to developing a general understanding of the regulatory frameworks for digital health products–with links and references to dive deeper as needed.
I think the regulatory chart/table for the different device categories is extremely helpful. I also think the outline for developing a fit-for-purpose regulatory strategy provides key guidance to unify the development of trusted digital health products.
The emphasis for a fit for purpose reg strat is practical and not just a theoretical concept that I plan to back to work.
Despite being one of the instructors in the course, I definitely learned one or two new things. However, maybe more importantly, the well thought through course structure really lends itself to seeing the bigger picture of digital health product regulation and how to use it to frame product development.
With the knowledge gained from this course I will now be able to confidently guide my digital health clients on every stage of developing and implementing a robust regulatory strategy.
Amazing content overall!
Working daily with med-tech start-ups this course will help us guide them through regulatory challenges, defining a pathway to move forward.
One of my clients has a new clinical research program and is open to innovation. We will develop technologies that reach patients and clinicians, and we will need to work closely with the FDA. I will return to this course to refresh on needed actions and take advantage of the organized, linked external resources and explanations. This course also provides the evidence we need to justify early and often communication with the FDA.
Great and comprehensive course about the regulatory strategy one has to consider while developing a digital health solution
Engaging Courses
Interactive sessions cater to a variety of learning styles with videos, knowledge checks to test your understanding, and real-world examples.
Flexible Learning
You’re busy, and so is your team, so our courses are designed to deliver the material efficiently, but our platform is designed so you can return as many times as you need.
Relevant Content
Digital medicine is a fast paced field. We leverage our community to deliver up to date information from actively engaged, diverse experts.
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