Good regulatory strategy is good business strategy

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

Regulatory-Strategy-for-Digital-Health-Products-in-the-US_DiMe_RegPath-1

Develop Your Regulatory Strategy

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.

Identifying your Role in Driving Regulatory Strategy for Digital Health Products

Identifying-your-Role-in-Driving-Regulatory-Strategy-for-Digital-Health-Products_DiMe_RegPath

Tidepool’s Regulatory Journey Case Study

Tidepool’s Regulatory Journey_Case Study_ DiMe_RegPath

Caption Health ‘s Regulatory Journey Case Study

Caption Health’s Regulatory Journey_Case Study_ DiMe_RegPath

Digital Health Product Categorization Guide_DiMe_RegPath

Digital Health Product Classification Toolkit

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.

Risk Assessment Model for Digital Health Product Lifecycle

Risk Assessment Model for Digital Health Product Lifecycle_DiMe_RegPath

5-Step Approach to Classifying Your Digital Health Product in the U.S.

5-Step Approach to Classifying your Digital Health Product Class in the U.S._DiMe_RegPath

Quick Guide on Intended Use and Indication for Use for Digital Health Products

Quick Guide on Intended Use and Indication for Use for Digital Health Products_DiMe_RegPath

Decision Map: Digital Health Product Classification

Decision Map_ Digital Health Product Classification_DiMe_RegPath