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The Software as a Medical Device (SaMD) market is projected to skyrocket from $3.81 billion in 2025 to over $19.58 billion by 2030. But lengthy Regulatory reviews (12–24 months in the US and EU) are stalling innovation.
The International Medical Device Regulators Forum (IMDRF) offers a solution: a standardized, two-dimensional risk categorization framework. This model aligns software risk with clinical impact, considering Healthcare Situation Criticality and Information Significance.
Implementing early IMDRF risk categorization can lead to:
- 23% success rates for multi-jurisdictional approvals.
- 6–8 months reduction in approval timelines.
- 12–18% in cost savings.
Download this whitepaper now to learn:
- How to use the IMDRF matrix to classify your SaMD (Categories I–IV).
- The impact of recent updates like N81 and Good Machine Learning Practice (N88).
- A roadmap to convert Regulatory complexity into a strategic advantage for quicker market access.
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