Quality, Compliance & Regulatory - software & AI news

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

Showing 92 results
Press release cover image

Sep 14, 2026

MediBeacon passes three audits in six weeks with zero major findings using Greenlight Guru

Medical device company relied on Greenlight Guru's eQMS to stay audit ready across ISO 13485, MDSAP, and MDR reviewsINDIANAPOLIS, Sept. 14, 2026 /PRNewswire/ -- Greenlight Guru, the leading provider of quality management, product development, and clinical data solutions for medical device companies, today announced that longtime customer MediBeacon passed three audits in a six-week span with zero major findings, using Greenlight Guru's eQMS to manage every stage of preparation and review.MediBea
Press release cover image

Sep 14, 2026

MethodSense Launches LuminLogic NextGen to Transform MedTech Compliance

AI-Enabled Platform Embeds 25+ Years of Regulatory and Quality Expertise to Accelerate Product CommercializationRALEIGH, N.C., Sept. 14, 2026 /PRNewswire/ -- Today MethodSense® announced the launch of LuminLogic® NextGen, a new AI-enabled quality and regulatory compliance platform that unifies eQMS, regulatory intelligence, submission readiness, and compliance management into a single solution. The platform delivers a fully configured, compliance-ready system in as little as one day rather than
Press release cover image

Sep 10, 2026

MHK and MCG Partner to Connect Evidence-Based Clinical Guidance with Standards-Based Prior Authorization

New integration to help health plans streamline prior authorization and prepare for CMS-0057-F complianceSEATTLE, Sept. 10, 2026 /PRNewswire/ -- MCG Health, part of the Hearst Health network and the industry's source of truth for trusted clinical guidance, announces a newly certified integration with MHK, a leading healthcare technology provider and a sibling Hearst Health company. The new integration connects the MCG Path interoperability solution directly with the MHK CareProminence prior auth
Minimalist illustration of a medical device and digital format

Sep 3, 2026

News by ACCESS Newswire on TradingView, 2026-09-03

DistillerSR is set to play a pivotal role in the DIGICAP project, aimed at revolutionizing the conformity assessment process for medical devices and in vitro diagnostics across Europe.The DIGICAP initiative, backed by €4 million in funding from the Horizon Europe program, unites 19 organizations from 12 EU countries to transition from traditional document-based assessments to a more efficient, machine-readable format. DistillerSR, recognized as one of five key technology providers, will collabor
Press release cover image

Sep 3, 2026

TraceLink and Omnicell Integrate DSCSA Compliance Solution into Hospital Pharmacy Operations

Integration brings serialized product verification and traceability directly into medication receiving workflows, intended to enable more efficient pharmacy operations without separate compliance processes.BOSTON, Sept. 3, 2026 /PRNewswire/ -- TraceLink, the world's largest Agentic Business Network for the life sciences and healthcare supply chain, today announced an integration between its Drug Supply Chain Security Act (DSCSA) compliance solution and the pharmacy inventory management systems o
Press release cover image

Sep 2, 2026

Codoxo Named a Winner in 2026 Fierce AI Innovation Awards

AI-powered Point Zero Payment Integrity recognized for helping health plans prevent payment errors before claims are created.DULUTH, Ga., Sept. 2, 2026 /PRNewswire/ -- Codoxo, the leading provider of AI and generative AI-powered healthcare payment integrity solutions, today announced that its Point Zero Payment Integrity solution has been named the winner in the "AI Innovation in Regulatory & Compliance" category of the 2026 Fierce AI Innovation Awards.Selected following a rigorous review by
Press release cover image

Sep 2, 2026

Systech Launches TraceIQ, Helping Transform Pharmaceutical Traceability from Compliance to Operational Intelligence

DOWNERS GROVE, Ill., Sept. 2, 2026 /PRNewswire/ -- Systech, part of Markem-Imaje and Dover and a leading provider of pharmaceutical serialization and traceability solutions, today announced the launch of Systech TraceIQ™, an intelligent and intuitive enterprise traceability platform created for a new operational reality in pharmaceutical supply chains.Backed by Systech's four decades of packaging execution and serialization expertise, TraceIQ combines core compliance capabilities with an operati
Press release cover image

Sep 2, 2026

MD Integrations Partners With LegitScript, Offering Telehealth Brands Expedited Path to Compliant Launch

MD Integrations is partnering with LegitScript as an Enterprise Certification Partner, offering expedited certification packages to virtual care and telehealth brands seeking compliance as a competitive advantage.NEW YORK, Sept. 2, 2026 /PRNewswire/ -- MD Integrations, the only unified telehealth platform built on a nationwide, doctor-only network, announced a partnership with LegitScript. The partnership embeds LegitScript certification directly into MD Integrations' onboarding workflow, giving
Press release cover image

Sep 2, 2026

Eugia Pharmaceuticals Goes Live with ValGenesis to Modernize CSV

SANTA CLARA, Calif.--(BUSINESS WIRE)--ValGenesis, Inc., the leader in enterprise digital validation, announced that Eugia Pharmaceuticals, a global specialty pharmaceutical company, has gone live with ValGenesis to modernize computer system validation (CSV) processes across its sites in India. The deployment will help enhance compliance, improve operational efficiency, and support growth.Hyderabad-based Eugia Pharma, a subsidiary of Aurobindo Pharma, develops and markets complex generics. The co
A vial of medication on a lab bench in a dimly lit pharmaceutical lab.

Sep 1, 2026

TraceIQ Launched to Maximize Pharmaceutical Traceability

Systech has introduced TraceIQ, a new enterprise traceability platform aimed at enhancing the operational efficiency of pharmaceutical and biopharma supply chains.TraceIQ represents a significant advancement from earlier traceability systems, which primarily focused on meeting serialization mandates and ensuring regulatory compliance. According to Sreedhar Patnala, Systech's general manager, while compliance remains crucial, it is not sufficient in today’s complex supply chain landscape. As regu
Press release cover image

Aug 27, 2026

FDA Inspection Data Reveals a New Compliance Blind Spot for Medical Device Makers

As the FDA deploys AI to analyze submissions at scale, the first QMSR inspection cycle shows problems are spreading across entire quality systems, not just single departmentsSALT LAKE CITY, Aug. 27, 2026 /PRNewswire/ -- Newly surfaced inspection data from the first months of the FDA's Quality Management System Regulation (QMSR) shows a tough new reality for life sciences teams: investigators are no longer looking at procedural gaps in isolation. Instead, they're uncovering interconnected problem
Press release cover image

Aug 20, 2026

Berry Street Adds SOC 2 Type II to Its Compliance Program as Payer and Enterprise Partnerships Expand

Independent third-party audit validates the company's controls for security, availability, and confidentiality as it scales nutrition therapy across all 50 statesNEW YORK, Aug. 20, 2026 /PRNewswire/ -- Berry Street, the nutrition therapy platform connecting patients to insurance-covered care from Registered Dietitians, today announced it has achieved SOC 2 Type II certification, meeting a key security requirement for the health plans, health systems, and enterprise partners it serves.Conducted b