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

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

fda guidance digital health samd software as a medical device regulatory compliance clinical decision support medical device software ai medical devices cybersecurity

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

fda pccp medical device regulation ai/ml devices section 515c fdora 2022 software as a medical device regulatory compliance 510(k) submission change management

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

fda regulation samd classification ai medical devices machine learning 510(k) clearance de novo pathway software as a medical device regulatory compliance

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

eu mdr ai medical devices eu ai act medical device regulation software as a medical device regulatory compliance conformity assessment mdcg guidance risk management samd

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

Learn about the FDA's AI/ML medical device tracker. We analyze authorization trends, key statistics by specialty, and the 510(k) regulatory pathway for approval

20 min read

11/10/2025

fda regulation ai in medicine medical devices software as a medical device 510(k) clearance ai in radiology medtech digital health

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