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 (SaMD). They wanted to know the optimal regulatory pathway for ANZA, EU, and US.
Solution
- Built and supported a Quality Management System
- Re-built a Design History File in compliance with Global Standards
- Developed a clinical trial strategy for EU and FDA pathways
Results
The client received strategic regulatory support for compliant Quality Management following international standards, enabling their market expansion.
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