Explore product investigation intelligence.
Learn how MDARIX connects product reality, evidence, temporal context, investigation, decisions, assurance, and governance.
Follow an investigation from signal to decision.
See how MDARIX moves from a product signal to a traceable, reviewable decision while keeping evidence, uncertainty, and human authority visible.
Complaint increases, product changes, supplier issues, affected lots, and missing evidence.
See the scenariosAI assurance, provenance, role boundaries, audit trails, and controlled human review.
Review trust controlsDiscover, develop, prove, release, monitor, improve, and evolve with connected context.
Explore lifecycleDirect answers to the questions quality teams ask.
Trending complaints, reportability, the risk file and CAPA effectiveness: a short answer first, then the explanation and what MDARIX does about it.
Count clusters, compare each version's rate with its own history, and use units in the field.
21 CFR Part 803 and EU MDR Article 87 in brief: what is reportable, by when, and who decides.
ISO 14971:2019 clause 10 in brief: review field information for safety and record every risk review.
A trend is a measurement over time; a signal is an observation a person triages.
Set the criteria before the action, measure from the right date, and sign what you found.
Yes: a free 30-day trial, requested on the website, with sample data first and then your own exports.
Watch the free trial, step by step.
Fourteen short videos follow a quality manager through the 30-day trial, from signing up to every chapter of the story, with English captions.
AI, safety signals, and post-market surveillance.
Explore how medical-device teams monitor real-world performance, investigate emerging signals, and keep AI-enabled devices under human oversight across the product lifecycle.
Post-market signals
Medical-device post-market surveillance signals reviewed by a quality team.
AI lifecycle monitoring
AI-enabled medical device lifecycle monitoring and performance review.
Regulatory intelligence
Regulatory intelligence and source provenance for AI medical devices.
Current regulatory and industry publications for MedTech teams.
Curated links to official regulator and public-health sources. MDARIX does not replace regulatory advice; use the original source for the current text, scope, and applicability.
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (draft guidance)
FDA draft guidance, announced in January 2025, on lifecycle management and marketing submissions for AI-enabled device software, including transparency, bias and performance monitoring after release.
Open official sourcePostmarket Surveillance under Section 522
Final guidance on active, systematic, scientifically valid collection, analysis, and interpretation of marketed-device information.
Open official sourceMDCG 2025-10: Post-market surveillance guidance
European Commission guidance for post-market surveillance of medical devices and in vitro diagnostic medical devices.
Open official sourceMDCG 2025-6: FAQ on the interplay between the MDR/IVDR and the AI Act
Joint guidance discussing post-market monitoring, interaction with other AI systems, and integration with existing MDR/IVDR monitoring plans.
Open official sourceGuidance for post-market surveillance and market surveillance of medical devices
A practical framework for collecting and evaluating experience from marketed devices and identifying when action may be needed.
Open official sourceGenerating evidence for AI-based medical devices
Framework for training, validation, evaluation, and post-deployment monitoring of AI-based medical devices.
Open official sourceFDA AI-enabled medical device list
Reference list of AI-enabled devices authorized for marketing in the United States; useful for landscape and surveillance research.
Open official sourceFDA postmarket requirements and safety monitoring
FDA overview of reporting, device tracking, surveillance studies, recalls, and other postmarket obligations and resources.
Open official sourceBring one real investigation. See the whole story in one place.
Start with exports from your quality, product and supplier systems. Your systems of record stay where they are.