Quality, Compliance & Regulatory - software & AI news

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

Showing 124 results
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Oct 14, 2026

TRI Introduces AI-driven Risk Assessment and Connected Oversight in Latest OPRA Release

CAMBRIDGE, England, Oct. 14, 2026 /PRNewswire/ -- TRI has announced the latest release of OPRA, its risk-based quality management (RBQM) platform. The release introduces a connected approach to RBQM that takes teams from protocol analysis to live oversight without breaking the chain of evidence between them.As clinical research moves towards more proportionate, risk-based quality management, teams need more than a static risk assessment. They need to know which risks matter, how they are being c
A surgical instrument on a workbench in a clinical setting.

Oct 11, 2026

European medical device manufacturers rethink product development strategies

European medical device manufacturers are evolving their product development strategies in response to technological advancements and regulatory changes, according to a recent report by Information Services Group (ISG).The ISG Provider Lens Medical Device Digital Services report highlights a shift in how these manufacturers approach technology investments, emphasizing the need for proven business value and long-term viability before scaling new initiatives. As medical devices increasingly incorp
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Oct 11, 2026

AnX Robotica Highlights Documented ProScan AI Workflow Performance from Submission to FDA

Separate FDA submissions report mean small-bowel capsule review-time reductions of 88.6% with ProScan-assisted reading and 24.7% with a recently cleared comparator AI-assisted workflow.PLANO, Texas, Oct. 11, 2026 /PRNewswire/ -- AnX Robotica today highlighted the documented results of clinical performance of NaviCam® ProScan™, its AI-assisted capsule endoscopy reading technology, following a recent U.S. Food and Drug Administration clearance of another AI-assisted capsule endoscopy platform.In i
A medical device on a workbench in a dimly lit lab, highlighting its circuit board.

Oct 8, 2026

Cybersecurity by Design: Building Traceable Execution Across the MedTech Lifecycle

As medical devices increasingly rely on software and connectivity, integrating cybersecurity into the entire product lifecycle is becoming essential for patient safety and regulatory compliance. Traditional approaches that treat cybersecurity as a final step are proving inadequate, leading to a need for a more cohesive strategy.The article highlights the importance of shifting cybersecurity responsibilities upstream in the engineering process. By establishing security requirements early and main
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Oct 8, 2026

The EHS Workflow Gaps That Cost Life Sciences Manufacturers During Inspections

Most life sciences manufacturers that run into troubleduring an inspection already have the programs that pharmaceutical EHScompliance calls for. There is a hazard communication plan, a waste contingencyplan and a corrective action procedure. The finding tends to land somewhere else: in the step wherea record should have changed and didn't, because the work passed from one teamto another and nobody owned the handoff.An EHS gap in pharmaceuticals is the distance between what asite's procedures re
Minimalist illustration of a presentation slide with microbial culture

Oct 8, 2026

Microbix Making Keynote Presentation at Masters Summit 2026

Microbix Biosystems Inc. is set to deliver a keynote presentation at the upcoming Masters Summit 2026, focusing on their integration of an Electronic Quality Management System (eQMS). This event, hosted by MasterControl, will take place from October 12-15, 2026, in Salt Lake City, Utah, and will gather over 600 professionals from the life sciences sector.The presentation will be led by Microbix’s IT Manager and QC Project Lead, who will discuss the company's journey in implementing MasterControl
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Oct 7, 2026

Zivian Health Launches Elevate, an AI Chart Review Tool for Clinical Oversight at Scale

Elevate automates the chart review cycle from end to end, delivering 90% cost savings in administrator, collaborating physician, and clinician time.AUSTIN, Texas, Oct. 7, 2026 /PRNewswire/ -- Zivian Health, the compliance infrastructure behind multi-state clinical workforces, today announced the launch of Elevate, an AI chart review tool that enables organizations to grow their workforce and expand into new markets more quickly, with less risk, and at a fraction of the cost when compared to manu
A pharmaceutical vial in a warehouse setting

Oct 7, 2026

Q&A: Software's Next Role In Pharma Supply Chains

In an insightful discussion, Mark Beers from Swisslog highlighted the pivotal role software plays in evolving pharmaceutical supply chains to meet new demands.As pharmaceutical companies increasingly focus on biologics and specialty medicines, many existing warehouses and automation systems are ill-equipped to handle these changes. Beers emphasizes that software serves as a crucial link between outdated infrastructure and the dynamic needs of modern product and regulatory landscapes. This adapta
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Oct 6, 2026

Pharmacy Language Access Is a Code-Red Patient Safety Problem, RxTran White Paper Warns

Report urges pharmacists and legislators to treat unverified prescription translation as a clinical risk as more states adopt label translation lawsKey takeaways:RxTran, a division of Language Scientific, released Pharmacy Language Access Is a Code-Red Problem, a white paper finding that pharmacies can comply with every state prescription label law and still dispense labels that patients with limited English proficiency can't read.More than 28 million U.S. residents have limited English proficie
Flat illustration of a medical device with monitoring signals

Oct 6, 2026

UK unveils new policy to constantly monitor AI-based medical devices

The U.K. has announced a groundbreaking policy for the continuous monitoring of AI-based medical devices, a significant shift from the previous single-check approach.The Medicines and Healthcare products Regulatory Agency (MHRA) will oversee ongoing evaluations of these devices, responding to recommendations from the National Commission into the Regulation of AI in Healthcare, which were accepted by the government on October 6. An implementation roadmap is expected to be released in the spring o
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Oct 5, 2026

ValGenesis to Bring Real-World AI-Assisted Validation Insights to KENX Europe 2026

Company will share lessons learned from customer pilots and production deployments as life sciences organizations move AI from experimentation to practical GxP useSANTA CLARA, Calif.--(BUSINESS WIRE)--#AIinGxP--ValGenesis Inc., the leader in enterprise digital validation, will explore real-world insights into the practical application of AI-assisted validation at KENX Europe 2026: Harnessing the Power of AI in GxP, taking place Oct. 14–15, 2026, at the Four Elements Hotel Amsterdam in Amsterdam,
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Sep 30, 2026

Medtronic announces regulatory milestones for newest cardiac mapping and ablation software

FDA clearance and CE Mark for latest Affera™ Prism-2 Mapping Software expand cardiac mapping capabilitiesCE Mark for PulseSelect ProxBox™ Adapter with Proximity Indicator software adds real-time tissue proximity feedbackGALWAY, Ireland, Sept. 30, 2026 /PRNewswire/ -- Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced regulatory milestones for software used with two cardiac ablation platforms. This includes U.S. Food and Drug Administration (FDA) clearance and CE Mar