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Good regulatory strategy is good business strategy

Build a fit-for-purpose regulatory strategy for better commercial decision-making and success.

Develop your regulatory strategy

Regulatory Strategy for Digital Health Products in the U.S.
A comprehensive regulatory strategy is critical for the success of digital health products. Now that you’ve identified your appropriate pathway, use these toolkits to carefully plan and implement a low-risk, successful regulatory review process that integrate into your overall business plan.

Digital Health Product Classification Toolkit

Digital Health Product Categorization Guide
A comprehensive regulatory strategy is critical for the success of digital health products. Now that you’ve identified your appropriate pathway, use these toolkits to carefully plan and implement a low-risk, successful regulatory review process that integrate into your overall business plan.

Identify

Use the RegPath tool and other resources to navigate and identify your regulatory pathway.

Build

Create and integrate a fit-for-purpose regulatory strategy into your business plan for commercial success.

Interact

Ongoing, interact with regulators to develop digital health products that best meet your goals and patients’ needs.

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Help streamline the path to regulatory and commercial success to optimize health outcomes for the greatest number of patients

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