Quality, Compliance & Regulatory - software & AI news

Daily news on software, AI, and companies shaping quality, compliance & regulatory.

Showing 92 results
A minimalist illustration of a medical device and AI technology.

Jul 7, 2026

MDUFA VI Draft Commitment Letter Includes Faster Pre-Submission Lane, Expanded AI Commitments

The FDA's recent draft commitment letter for MDUFA VI introduces significant changes aimed at enhancing the medical device approval process. Published on July 7, the draft outlines a tiered pre-submission lane designed to expedite the review process for medical devices. This new framework allows for more streamlined interactions between device developers and the FDA, potentially reducing time to market. Additionally, the commitment letter emphasizes an increased focus on digital health technolog
A clipboard with a checkmark representing regulatory compliance in clinical trials.

Jul 3, 2026

VEEV - AI-Powered Veeva Systems Poised for Solid Growth Amid Regulatory Stability

Veeva Systems (NYSE: VEEV) is carving out a significant role in the life sciences sector, leveraging artificial intelligence (AI) to enhance its already robust offerings in clinical trials, regulatory submissions, and drug safety.Veeva stands apart from typical cloud-software companies by embedding its systems deeply within the operational frameworks of pharmaceutical and biotechnology firms. This integration creates substantial switching costs, as changing vendors involves significant risks rel
A vial of pharmaceutical liquid on a lab bench in a quality control lab

Jul 3, 2026

As India expands QR tracking, pharma industry looks to AI for quality

India's recent expansion of QR code tracking in the pharmaceutical sector aims to enhance the authenticity and transparency of life-saving medicines, now including a broader range of products like antimicrobials and anti-cancer drugs. This initiative is part of a "track-and-trace framework" designed to improve supply chain integrity.The government's data indicates a significant increase in drug sample testing, with samples rising from 84,874 in 2020-21 to 116,323 in 2024-25. While the annual det
Flat illustration of a stethoscope in a medical context

Jul 2, 2026

Update: AI-Enabled Medical Devices and IVDs Confirmed as “High-Risk”

The recent agreement on the AI Act confirms that AI-enabled medical devices and in vitro diagnostics (IVDs) are classified as “high-risk.”This classification follows the political consensus reached on the Digital Omnibus on AI, which clarifies that these devices, already regulated under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), will also be subject to the AI Act’s stringent requirements. Specifically, an AI system qualifies as high-risk if it is either a prod
A minimalist illustration of a document with a checkmark, symbolizing certification in AI governance.

Jul 2, 2026

Greenlight Guru achieves ISO 42001 certification for AI governance across medtech quality and clinical solutions

Greenlight Guru has recently achieved ISO/IEC 42001:2023 certification for its Artificial Intelligence Management System, marking a significant milestone in AI governance for medtech. This certification applies to the company's electronic Quality Management System (eQMS) and clinical electronic data capture (EDC) products, providing medical device companies with verified documentation for audits and vendor qualifications.The ISO 42001 certification assesses an organization's ability to manage AI
A minimalist illustration of a document with a checkmark, symbolizing regulatory approval in AI.

Jul 1, 2026

Exponential Growth Forecasted for AI in Regulatory Affairs Market: From $1.71 Billion in 2025 to $4.78 Billion by 2030

The AI in Regulatory Affairs market is set for significant growth, projected to escalate from $1.71 billion in 2025 to $4.78 billion by 2030. This expansion, characterized by a compound annual growth rate (CAGR) of approximately 22.7%, is driven by increasing regulatory complexities, a surge in documentation, and the demand for faster approvals within the life sciences sector.The report highlights key trends such as the adoption of AI-driven regulatory intelligence platforms and automated submis
Minimalist illustration of a sensor and actuator for diagnostic instruments

Jul 1, 2026

HiArc to Feature New Control System for Diagnostic Instruments at ADLM 2026

HiArc is set to unveil its innovative control system for diagnostic instruments, aimed at expediting the development process for medical devices, at the upcoming ADLM 2026 conference in Anaheim, California.The HiArc Ctrl platform merges hardware and software to facilitate quicker transitions from concept to prototype for engineering teams. By offering a ready-to-use control architecture, it enables real-time interfacing with sensors and actuators, while ensuring compliance with regulated clinica
A compliance document and regulatory checklist on a desk

Jul 1, 2026

Does Veeva (VEEV) Index Removal Obscure a Deeper Shift Toward AI-Driven Regulated Workflows?

Veeva Systems is navigating a pivotal moment as it enhances its AI capabilities while facing removal from several Russell growth indices.In June 2026, Veeva Systems introduced Veeva EHS and expanded its AI tools with Falcon MLR, aimed at automating compliance and regulatory workflows for life sciences clients. This move underscores the company's commitment to integrating AI into its platform, aligning with the growing demand for efficiency in regulated environments. However, Veeva's recent exclu
A minimalist illustration of a car and gear symbolizing automotive quality.

Jun 27, 2026

Tata Motors to sharpen focus on product quality, service

Tata Motors is refocusing its efforts on enhancing product quality and service after a period of significant growth in passenger vehicle volumes. CEO Shailesh Chandra highlighted the company's strategy to proactively improve quality through the integration of AI, digital engineering, and total quality management (TQM).The company has reported a nearly 60% reduction in early-life vehicle issues, attributing this improvement to stricter quality controls and enhanced logistics. Chandra acknowledged
Researcher reviewing regulatory documents in a lab

Jun 26, 2026

Domino, Appsilon Advance Open Source AI For Regulated Pharma

Domino Data Lab and Appsilon have joined forces to enhance the integration of open-source AI into regulated environments within the life sciences sector. This collaboration aims to streamline the transition from AI development using R and Python to compliant production workflows.The partnership seeks to address a significant hurdle in the industry: many AI initiatives utilizing open-source tools struggle to reach production due to the absence of validated infrastructures that meet regulatory sta
A surgical instrument on a clinical table

Jun 25, 2026

Former Medtronic CEO Bill Hawkins Joins Ketryx Board to Solve the AI Bottleneck in Life Sciences

Ketryx has strengthened its leadership by appointing former Medtronic CEO Bill Hawkins to its Board of Directors, aiming to tackle the challenges associated with AI integration in life sciences.William A. Hawkins brings a wealth of experience to Ketryx, having previously led Medtronic as Chairman and CEO. His involvement is expected to enhance Ketryx's mission of streamlining product development in safety-critical industries such as medical devices and pharmaceuticals. Ketryx's platform focuses
A biologics sample on a lab surface with testing equipment in the background.

Jun 23, 2026

WuXi Biologics wins fourth EMA certification for Suzhou Biosafety Center

WuXi Biologics has achieved a significant milestone by obtaining its fourth Good Manufacturing Practice (GMP) certification from the European Medicines Agency (EMA) for its Suzhou Biosafety Testing Center, with no critical findings reported during the inspection.This recent certification underscores the facility's importance as a global quality center for biologics testing, facilitating European Union marketing authorizations for 19 biologic products from 13 clients. The products in question inc