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 document with a checkmark, symbolizing approval in medical review processes.

May 18, 2026

Medical, Legal, and Regulatory (MLR) Review Software

The global market for Medical, Legal, and Regulatory (MLR) Review Software is experiencing significant growth, projected to expand from $13.1 billion in 2025 to $27.1 billion by 2032, reflecting a compound annual growth rate (CAGR) of 10.9%.This software is increasingly essential for organizations in the pharmaceutical and healthcare sectors, helping them navigate complex regulatory requirements efficiently. By centralizing the review and approval processes for promotional materials, clinical do
A stack of regulatory documents and a compliance checklist on a desk in a dimly lit office.

May 18, 2026

Medical, Legal, and Regulatory (MLR) Review Software Business Report 2026: A $27.1 Billion Market by 2032 from $13.1 Billion in 2025 - Rising Demand for Streamlined Compliance in Pharma and Biotech

The Medical, Legal, and Regulatory (MLR) Review Software market is poised for significant growth, with projections indicating a rise from $13.1 billion in 2025 to $27.1 billion by 2032, reflecting a compound annual growth rate (CAGR) of 10.9%.This growth is largely attributed to the increasing complexity of regulatory requirements and the pressing need for organizations in the pharmaceutical and biotechnology sectors to streamline compliance processes. MLR review software serves as a vital resou
A regulatory stamp with a checkmark symbolizing oversight in AI medical devices.

May 15, 2026

FDA Rejects Proposal to Ease Oversight of AI Medical Devices

The FDA has opted not to relax its oversight of certain AI medical devices, emphasizing the importance of patient safety amid rapid technological advancements.The U.S. Food and Drug Administration (FDA) recently rejected a proposal from Harrison.ai, an Australian health AI firm, which sought to ease premarket review requirements for specific AI-enabled diagnostic tools. The company argued that developers with prior approvals and robust post-market monitoring should face fewer regulatory hurdles.
A syringe and medical chart in a clinical setting

May 14, 2026

MedTech Abandons Legacy Tools for AI-Powered Development Platforms

The MedTech industry is undergoing a significant transformation as companies increasingly shift from outdated legacy systems to advanced AI-driven platforms, enhancing innovation and compliance while improving patient outcomes.Recent developments highlight a pivotal trend in the medical technology sector, where organizations are moving away from traditional, fragmented software solutions. Enlil, Inc., an AI-powered traceability platform, recently reported a record first quarter in 2026, securing
Minimalist illustration of a medical imaging device

May 14, 2026

Enlil Caps Record Q1 2026 with Eight New MedTech Customers

Enlil has achieved a significant milestone in Q1 2026 by onboarding eight new MedTech customers, showcasing a shift towards integrated AI-powered traceability solutions in the medical device sector.During the first quarter of 2026, Enlil welcomed a diverse group of eight MedTech innovators, ranging from organ perfusion to AI-driven imaging, all opting to transition from legacy quality and product lifecycle management (PLM) systems. This trend indicates a broader movement within the MedTech indus
A minimalist illustration of a cloud with an upward arrow, representing cloud technology and data flow in life sciences.

May 12, 2026

Veeva Systems Partnerships Deepen Role As Core Life Sciences Cloud Platform

Veeva Systems is solidifying its position as a fundamental player in the life sciences cloud sector through strategic partnerships with Smith+Nephew and Snowflake.The collaboration with Smith+Nephew aims to centralize global quality management using Veeva Quality Cloud, while the partnership with Snowflake will integrate Veeva's Vault Platform with Snowflake’s AI Data Cloud for enhanced data analytics in life sciences. These moves indicate a shift from Veeva being viewed as a standalone solution
A compliance document and pen on an office desk with a city view in the background.

May 9, 2026

Modicus Prime Announces $8M in Funding to Enable AI Audit Readiness Across Pharma

Modicus Prime has successfully secured an additional $4.5 million in funding, raising its total to $8 million, aimed at enhancing its Trustworthy AI Compliance Software for the pharmaceutical sector.This funding round, led by Frist Cressey Ventures, will facilitate the expansion of Modicus Prime's software, which is designed to ensure that AI applications within pharmaceutical companies meet regulatory compliance across various global environments. The platform integrates seamlessly with existin
A compliance document and pen on a desk in a dimly lit office

May 8, 2026

Modicus Prime: $8 Million Raised To Expand AI Compliance Infrastructure For Pharma

Modicus Prime has successfully secured $8 million in funding, bolstering its efforts to enhance AI compliance infrastructure within the pharmaceutical sector.The recent funding round, which included a significant $4.5 million investment from Frist Cressey Ventures, alongside contributions from Silverton Partners and Oncology Ventures, comes on the heels of the company's successful deployment of its Trustworthy AI Compliance Software. This software is aimed at pharmaceutical companies and other r
A clipboard with quality metrics in a pharmaceutical office setting.

May 6, 2026

New MasterControl Survey: Pharma Quality Teams Struggle to Get Employees Engaged With Quality Systems, a Hurdle for AI Ambitions

A recent survey by MasterControl highlights a significant concern within the pharmaceutical industry: while leaders are optimistic about AI's potential, they struggle with employee engagement in quality systems, which is crucial for AI implementation.The survey, involving 300 quality and manufacturing leaders in the life sciences sector, revealed that 94% of pharmaceutical quality leaders see poor employee adoption of quality systems as a major challenge. This issue raises questions about the fe
A flat illustration of an audit checklist representing compliance in pharma.

May 6, 2026

Modicus Prime Raises $8M to Enable AI Audit Readiness Across Pharma

Modicus Prime has successfully secured an additional $4.5 million in funding, bringing its total to $8 million, aimed at enhancing AI compliance in the pharmaceutical sector.Based in Austin, Texas, Modicus Prime has developed the Trustworthy AI Compliance Software, designed to ensure that AI applications in regulated environments meet audit requirements. This software integrates seamlessly with existing pharmaceutical tech stacks and quality management systems, serving as a centralized complianc
A flat silhouette of a regulatory document with a checkmark, symbolizing approval in MedTech.

May 5, 2026

Rimsys Launches the Regulatory Execution Engine for MedTech

Rimsys has unveiled its Spring 2026 release, a transformative platform designed to enhance regulatory operations for MedTech companies. This new system shifts focus from merely storing regulatory data to executing regulatory strategies effectively.The Spring 2026 platform introduces a suite of features aimed at improving the speed and efficiency of regulatory teams. Key components include AI-driven regulatory monitoring, which provides timely updates on regulations across over 90 countries, and
A compliance checklist on a desk in a dimly lit office

May 5, 2026

i-GENTIC AI Expands GENIE to Enforce Full FDA Compliance Lifecycle for Life Sciences

i-GENTIC AI has enhanced its GENIE platform to streamline compliance with FDA regulations throughout the product approval lifecycle in the life sciences sector.GENIE, a pioneering intelligence engine, translates complex regulatory requirements into machine-executable logic, facilitating real-time compliance. This innovation addresses a significant challenge faced by biopharma and medtech companies: ensuring consistency across vast amounts of documentation during the approval process. Zahra Timsa