Articles tagged with “medical-device-regulation”

FDA QMSR & ISO 13485: New Inspection Playbook Guide

Analyze the FDA QMSR final rule, ISO 13485 alignment, and the new CP 7382.850 inspection playbook. Learn key compliance steps for device manufacturers.

35 min read

2/27/2026

fda qmsr iso 13485 medical device regulation 21 cfr part 820 quality management system fda inspection risk management cp 7382.850 regulatory affairs medtech

FDA QMSR & ISO 13485: Key Changes Effective 2026

Analyze the FDA Quality Management System Regulation (QMSR) effective Feb 2, 2026. Learn how ISO 13485:2016 incorporation impacts medical device compliance.

50 min read

2/27/2026

fda qmsr iso 13485 medical device regulation 21 cfr part 820 quality management regulatory compliance fda inspection device manufacturers

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

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

ISO 14155 vs. ICH GCP: A Comparison for Device & Drug Trials

Learn the key differences between ISO 14155 for medical device trials and ICH GCP for pharma. This guide compares their scope, risk management, and regulatory c

40 min read

11/22/2025

iso 14155 ich gcp good clinical practice clinical trials medical device regulation ich e6 regulatory affairs

FDA 510(k) Explained: Medical Device Premarket Notification

Understand the FDA 510(k) premarket notification process for Class II medical devices. This guide covers substantial equivalence, predicate devices, and key ste

45 min read

11/14/2025

fda 510k premarket notification medical device regulation substantial equivalence predicate device class ii medical device regulatory affairs fda clearance

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

ai medical devices medical device regulation software as a medical device fda guidance eu ai act ai in healthcare algorithmic bias

The EU AI Act & Pharma: Compliance Guide + Flowchart

Learn about the EU AI Act's impact on pharma. Updated for 2026 with the Digital Omnibus proposal, GPAI Code of Practice, and revised Product Liability Directive. Includes risk classification, compliance steps, flowchart & SOP starter kit.

35 min read

10/18/2025

eu ai act pharmaceutical regulation ai in pharma high-risk ai compliance sop medical device regulation gxp

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