--- title: "Blog — Insights & Updates | QbD Group" description: "Stay informed with the latest regulatory insights, industry news, and expert perspectives from QbD Group." url: https://qbdgroup.com/en/blog type: "Page" language: en publisher: "QbD Group" citation: "QbD Group, \"Blog — Insights & Updates | QbD Group\", https://qbdgroup.com/en/blog" --- [FeaturedRegulatory AffairsQuality AssuranceOctober 21, 2026Your App Just Became a Medical Device. Now What?Your app qualifies as a medical device. Learn what EU MDR means for clinical evidence, Agile development, ISO 13485, CE marking and ongoing compliance.Read article](https://qbdgroup.com/en/blog/app-medical-device-eu-mdr-requirements) [Regulatory AffairsSoftware Solutions & ServicesQuality AssuranceOct 21, 2026Wellness App or Medical Device? Your Intended Purpose DecidesWhen does a wellness app become a medical device under the EU MDR? Explore intended purpose, software qualification, Rule 11 and common grey areas.Read more](https://qbdgroup.com/en/blog/wellness-app-or-medical-device-intended-purpose) [Software Solutions & ServicesRegulatory AffairsOct 14, 2026Why Existing In-House Data Rarely Gets IVD Software Through IVDRDiscover why in-house data often falls short of IVDR clinical performance requirements for IVD software and how to choose the right study design.Read more](https://qbdgroup.com/en/blog/ivd-software-in-house-data-clinical-performance) [Software Solutions & ServicesOct 14, 2026The Six Questions an Inspector Will Ask About Your AIIs your AI use inspection-ready? Explore six questions GMP inspectors may ask about AI governance, human oversight, model changes and validation.Read more](https://qbdgroup.com/en/blog/six-gmp-inspection-questions-ai-governance) [ClinicalOct 14, 2026Six Mistakes That Can Impact Your HPV Assay ValidationDiscover six common HPV assay validation mistakes, from sample selection and cut-off optimisation to population differences and platform changes.Read more](https://qbdgroup.com/en/blog/hpv-assay-validation-mistakes) [Software Solutions & ServicesRegulatory AffairsOct 14, 2026Bringing Your US-Authorised AI Diagnostic to Europe: What Transfers and What Doesn'tMoving an FDA-cleared AI diagnostic to Europe? Learn what evidence transfers, what IVDR requires and how a gap assessment can guide CE marking.Read more](https://qbdgroup.com/en/blog/fda-to-ivdr-ai-diagnostics-evidence-gap-assessment) [ClinicalOct 14, 2026One Study, Two Markets: Designing HPV Clinical Performance Studies for IVDR and WHO PQCan one HPV clinical performance study support both IVDR and WHO Prequalification? Learn how to align requirements and avoid duplicate studies.Read more](https://qbdgroup.com/en/blog/hpv-clinical-performance-studies-ivdr-who-pq) [ClinicalOct 14, 2026The Meijer Criteria Explained: Why They Matter for Your HPV AssayExplore the Meijer criteria for HPV assay validation, including clinical sensitivity, specificity, reproducibility and their role in IVDR and WHO PQ.Read more](https://qbdgroup.com/en/blog/meijer-criteria-hpv-assay-validation-ivdr-who-pq) [Software Solutions & ServicesOct 14, 2026Six Ways LLMs Can Trip You Up in GMPDiscover six risks of using LLMs in GMP, from hallucinations and inconsistent outputs to data leakage, and how to manage them responsibly.Read more](https://qbdgroup.com/en/blog/llm-pitfalls-gmp-generative-ai-risks) [Qualification & ValidationOct 7, 2026Why Annex 1 Implementation Doesn't End at the First CCS DraftAnnex 1 implementation does not end with your first CCS. Learn how to keep contamination control risk-based, current and inspection-ready.Read more](https://qbdgroup.com/en/blog/annex-1-implementation-contamination-control-strategy) [PharmacovigilanceOct 7, 2026Regulation (EU) 2025/1466: What Has Changed in Signal Management and Where We AreRegulation (EU) 2025/1466 changes EU signal management and EudraVigilance monitoring. Learn what MAHs need to implement and document.Read more](https://qbdgroup.com/en/blog/eu-2025-1466-signal-management-eudravigilance) [Regulatory AffairsOct 7, 2026The New EU Variations Guidelines: From New Rules to Better Variations ManagementThe new EU Variations Guidelines change classification, grouping, work-sharing and Type IA planning. Learn what this means for variations management.Read more](https://qbdgroup.com/en/blog/new-eu-variations-guidelines-variations-management) [Software Solutions & ServicesOct 1, 2026AI in GMP Is Not Banned. Here Is What Regulators Actually Expect.AI is not prohibited in GMP environments. Learn how intended use, risk, human oversight and existing quality controls determine compliant AI use.Read more](https://qbdgroup.com/en/blog/ai-in-gmp-regulatory-expectations) [Software Solutions & ServicesRegulatory AffairsSep 30, 2026Your IVD Software's Risk Class Alone Won't Tell You What Evidence You NeedRisk class alone does not determine the clinical evidence needed for IVD software. Learn what should actually drive your IVDR evidence strategy.Read more](https://qbdgroup.com/en/blog/ivd-software-risk-class-clinical-evidence) --- Source: https://qbdgroup.com/en/blog — © QbD Group. Quote freely with attribution and a link back.