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Software as a Medical Device (SaMD) is reshaping healthcare delivery, but it introduces a level of Regulatory, clinical, and operational complexity that traditional development models weren’t designed to handle.
This whitepaper presents a purpose-built SDLC framework tailored for SaMD one that aligns with FDA, EU MDR, and IMDRF expectations while supporting agile, scalable product delivery.
You will gain insight into:
- Designing risk-based, compliant development workflows
- Managing AI/ML integration, cybersecurity, and usability from the ground up
- Structuring post-market feedback and update cycles as strategic assets
- Reducing development inefficiencies and accelerating time to market
If you're leading SaMD initiatives, this resource offers the clarity and structure needed to scale responsibly and compete globally.
Fill the form below to download the White Paper
