Case Studies

Curated Regulatory Intelligence Augmented by AI

Medical Devices

Bringing Your SaMD to Market with Confidence and Compliance

Digital health is an emerging field that is revolutionizing the way healthcare is delivered. It combines technology, data, and analytics to improve diagnoses, treatment, and patient outcomes. Software-as-a-Medical-Device (SaMD), as a subsector of digital health solutions, is...

Medical Devices

Regulatory Guidebooks Paved the Way for Decentralized Clinical Trials

The adoption of hybrid and decentralized clinical trials (DCTs) has been accelerating across the world. According to Everest Group, 90% of the industry will incorporate some DCT components for their clinical trials by 2024. However, challenges have...

Medical Devices

Supporting Global Market Access for a MedTech Company

Read our case study and learn how RegASK leveraged its strategic regulatory expertise to help a medical device company fulfill regulatory requirements for global market access. Objective A MedTech startup wanted to launch its Software As a...

Medical Devices

How Product Classification Expertise was Pivotal to A Successful Market Entry

A Japanese manufacturer of support braces wanted to export its products to the E.U. market. They had a significant presence in Asia with a portfolio of over 30 SKUs but no presence in Europe. They had some...

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