Veranex Blog

FDA Regulatory (2)

6 min read

Readiness Checklist: Preparing for FDA's 2026 QMSR

Paige Sutton-Smith: Sep 2, 2025 10:24:59 AM

FDA Regulatory Quality

4 min read

Mastering the Pre-Submission Strategy: What to Ask (and Never Ask) the FDA About Human Factors

Veranex: Jul 28, 2025 3:33:37 PM

Human Factors FDA Regulatory

7 min read

Navigating FDA’s Latest Guidance Updates for AI-Enabled Medical Devices: A Marketing Submission Guide

Veranex: Jan 21, 2025 3:52:30 PM

FDA Regulatory Software Development AI

4 min read

Achieving Regulatory Clearance for a Novel Device – Provisio Medical

Veranex: Aug 6, 2024 1:19:11 PM

IVD FDA Regulatory Cardiovascular Preclinical

2 min read

Ensuring Compliance with New FDA Guidance on Software Documentation & Cybersecurity

Veranex: Jul 1, 2024 5:53:29 PM

FDA Regulatory Software Development Product Development

3 min read

Implications of FDA’s Quality Management System Regulation (QMSR) Final Rule

Veranex: Feb 21, 2024 12:16:08 PM

FDA Regulatory Quality Product Development

3 min read

The Role of Scientific/Medical Literature Screening and Review in Pharmacovigilance

Heidi Jerman: Nov 29, 2023 4:16:41 PM

FDA Regulatory Quality Medical Writing

5 min read

Understanding the ROI of Human Factors Engineering

Matt Gottschalk: Jul 27, 2022 11:29:36 AM

Human Factors FDA Regulatory Product Development

2 min read

FDA Releases Final Guidance on Oncology Therapeutic Class Labeling of Companion Diagnostics

Veranex: Apr 21, 2020 12:43:18 PM

IVD FDA Regulatory Regulatory

1 min read

The VALID and VITAL Acts: What Do They Mean for Diagnostic Innovators?

Veranex: Apr 6, 2020 12:45:46 PM

IVD FDA Regulatory Regulatory

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