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Navigating the regulatory landscape can be a mystery for digital innovators, making it challenging to understand how and when to interact with regulators. This course is designed to demystify this process by equipping you with essential knowledge on building an effective and purposeful regulatory strategy that will strengthen your business strategy and differentiate your products in today's competitive digital health market.
Identify Regulatory Landscape: Understand the current and evolving regulation landscape for digital health products as defined by FDA.
Craft a Robust Strategy: Learn about the components of an efficient regulatory strategy tlored to fit your specific product portfolio needs.
Ensure Successful Implementation: Gn skills necessary for effectively implementing your regulatory plan and engaging with regulatory authorities.
Explore the complexities of today’s digital health regulation, including FDA guidelines, evolving policies, and considerations that impact product development.
Deep dive into building principles like identifying regulated vs. unregulated products, choosing appropriate routes of approval, and preparing for pre-market interactions with regulators.
Learn practical steps to execute your regulatory strategy effectively, including strategies for overcoming common challenges faced by digital health product developers.
Bradley Merrill Thompson, Attorney at Epstein Becker Green - Expert in data science and legal aspects of technology regulation.
Jennifer Goldsack, CEO, Digital Medicine Society Inc. - A leader in digital health innovation with extensive experience in regulatory strategy development.
Julia Croxen, Rock Health Digital Health Strategy Consultant - Offers insights on the latest trs and best practices from industry leaders.
Shrawan Patel M.D., Managing Director at Strategy Health - Provides expertise on strategic planning for healthcare technologies, including digital health products.
Hear directly from our learners:
“I work with multiple health startups now, all in regulated spaces. This course has been invaluable in understanding the nuances of regulations and providing a framework to navigate them effectively.” – Matthew Potts Sr. Manager, Strategic Finance Business Analytics, Halo Precision Diagnostics.
The course structure is excellent for seeing the big picture of digital health product regulation and how it influences development decisions. – Omar Manejwalla, M.D. Chief Medical Officer, DarioHealth.
Upon successful completion, earn a Credly badge to showcase your professional growth in the field of digital healthcare.
The Digital Medicine Academy is dedicated to offering courses that are in line with the ever-evolving landscape of digital medicine. Stay tuned for additional course offerings!
Get in touch:
Address: 90 Canal Street, Suite 4th Floor, Boston, Massachusetts 02114
Phone: +1 765-234-3463
Eml: [email protected]
About DiMe
Defining Digital Medicine is at the core of our mission. Meet the team behind this vision, read insightful blog articles and stay updated on recent news. Explore career opportunities with us.
Navigate through our Digital Medicine Academy for comprehensive learning resources tlored to digital healthcare professionals. Dive into research publications and access a glossary of terms.
Join our slack community to connect, collaborate, and contribute to discussions about digital medicine advancements.
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