Articles tagged with “software-as-a-medical-device”

FDA PCCP Guide for AI/ML Software as a Medical Device

Understand FDA Predetermined Change Control Plans (PCCPs) for AI/ML Software as a Medical Device. Review Section 515C, FDA guidance, and implementation.

40 min read

4/16/2026

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FDA Digital Health Guidance: 2026 Requirements Overview

Analysis of FDA digital health guidance covering SaMD, AI, and cybersecurity. Understand 2026 updates, risk categorization, and regulatory compliance pathways.

50 min read

2/24/2026

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FDA PCCP Explained: Managing Medical Device Changes

Explore the FDA PCCP framework for medical devices. Understand Section 515C requirements for pre-approving AI/ML software changes without new submissions.

35 min read

2/9/2026

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FDA SaMD Classification: AI & Machine Learning Guide

Understand FDA SaMD classification for AI/ML devices. Review risk levels (Class I-III), 510(k) pathways, and regulatory guidelines for medical software.

20 min read

2/9/2026

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Clinical Evidence Requirements for AI Diagnostic Tools

Explore clinical evidence requirements for AI diagnostic tools. Covers FDA/EU regulations, prospective vs. retrospective validation, and performance standards.

35 min read

2/8/2026

ai diagnostic tools clinical evidence medical device regulation fda 510(k)clinical validation prospective studies software as a medical device eu mdr

EU MDR & AI Act Compliance for AI Medical Devices

Understand EU MDR and AI Act compliance for AI medical devices. Explains classification, conformity assessment, and technical documentation requirements.

40 min read

2/6/2026

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FDA's AI Medical Device List: Stats, Trends & Regulation

Learn about the FDA's AI/ML medical device tracker. With 1,451 devices authorized through 2025 and 295 cleared in 2025 alone, we analyze authorization trends, specialty breakdown, foundation model milestones, and the evolving regulatory framework

20 min read

11/10/2025

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AI Medical Devices: 2025 Status, Regulation & Challenges

Analysis of AI medical devices in 2025. Learn about market growth, 950+ FDA-cleared devices, new regulations like the EU AI Act, and key clinical challenges.

50 min read

10/30/2025

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Digital Therapeutics Market: 2025 Analysis & Growth Trends

Explore the digital therapeutics (DTx) market. This analysis covers market size, growth trends, key drivers, regulatory frameworks, and future outlook for 2025.

50 min read

10/18/2025

digital therapeutics dtx digital health software as a medical device healthcare technology clinical outcomes dtx market analysis

An Introduction to Software as a Medical Device (SaMD)

Comprehensive guide to Software as a Medical Device (SaMD): IMDRF definition, FDA QMSR and PCCP frameworks, EU MDR/AI Act compliance, real-world examples, and 2025-2026 regulatory updates.

35 min read

8/21/2025

samd software as a medical device imdrf medical device regulation digital health fda health tech