Quality, Compliance & Regulatory - software & AI news

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

Showing 124 results
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
A flat illustration of a microbial plate in a lab setting, symbolizing quality control in pharmaceuticals.

Jun 23, 2026

Clever Culture Systems: AI-driven plate assessment transforms pharma QC, unlocking scalable growth and recurring revenue

Clever Culture Systems is leveraging AI to enhance microbial quality control in pharmaceutical manufacturing, addressing significant inefficiencies and compliance issues.The company's APAS Independence system automates the assessment of microbial plates, providing a scalable solution that meets the high-throughput demands of the industry. This innovation not only streamlines quality control processes but also attracts major pharmaceutical clients, contributing to robust recurring revenue streams
Audit checklist on a desk in a quality assurance office

Jun 22, 2026

Piramal Pharma Solutions Highlights Strong Performance Across More Than 200 Customer Audits

Piramal Pharma Solutions (PPS) has recently reported significant achievements in customer audits and regulatory approvals, marking a pivotal year for the company. Over the past fiscal year, PPS completed more than 200 customer audits and secured over 70 approvals from various regulatory bodies globally, highlighting its commitment to quality and operational excellence.This accomplishment is rooted in PPS's comprehensive quality strategy, which emphasizes sustained compliance and continuous impro
Close-up of medical device packaging with new labeling symbols on a wooden table

Jun 18, 2026

Euro Roundup: Commission gives medtech companies 5 years to adapt to symbols standard

The European Commission has introduced a five-year transition period for medical device manufacturers to adapt to new harmonized standards, particularly regarding labeling symbols.Recently, the Commission revised standards affecting medical devices and diagnostics, specifically EN ISO 15223-1:2021, which dictates the symbols for conveying information on medical devices and their packaging. A key change is the replacement of “EC REP” with “EU REP” to denote “authorized representative.” This trans

Jun 18, 2026

EU draft guidelines sharpen high-risk AI classification for medtech and digital health

The European Commission has released draft guidelines aimed at clarifying the classification of high-risk AI systems within the medtech and digital health sectors. These guidelines are particularly significant for AI technologies that utilize physiological signals, such as gait analysis or ECG readings, to assess patient health, categorizing them as high-risk under the biometric use case.The draft guidelines, which are open for consultation until July 23, do not impose new obligations but provid