Current investigation capabilities anchor a broader lifecycle vision. Future areas are identified clearly without implying working functionality.
Each phase leaves design-control records: user needs, design inputs and outputs, verification, validation and the risk file. When a field problem appears, investigators trace back through those records, which is where MDARIX starts.
Feedback loop. A field problem is traced back through these records.
A product issue may involve a component, material, supplier, or supplier change. MDARIX helps teams connect supplier and component information with product records and emerging signals, supporting clearer investigations and impact assessments.
Components connect product design, suppliers, manufacturing, risk, and field performance. MDARIX helps teams see these relationships in context, making it easier to assess whether a component-related issue may affect other products or versions.
Lot and batch information can help teams assess the scope and distribution of a potential issue. MDARIX connects lot context with product, manufacturing, supplier, and post-market records to support structured investigation and impact review.
Changes to design, components, suppliers, processes, labeling, or software can affect requirements, risks, evidence, and products in the field. MDARIX helps teams connect change proposals to those relationships so impact assessments are supported by product context.
Post-market surveillance brings together complaints, adverse events, service information, returns, trends, and other field evidence. MDARIX connects this information to products, versions, lots, risks, investigations, and decisions so teams can review emerging signals in context.
A count rule and a trend check compare each product version's last 30 days with its own history, counted per unit in the field. A signal opens a case in one click with every complaint attached. Service, return and adverse-event feeds come later.
Evidence is most useful when reviewers can see the product question, risk, investigation, or decision it supports. MDARIX preserves source, version, date, provenance, contradictions, limitations, and missing links across the lifecycle.
A signed decision opens its CAPA, and MDARIX shows which CAPAs were closed without an effectiveness check, which checks are overdue and which have none planned. The full CAPA workflow stays in your QMS.
Future roadmap areas are informational and do not represent available workflows or committed release dates.
Products, versions and lots, temporal context, the second look at closed complaints, reporting clocks, signals and trend checks, investigations with evidence, hypotheses and open questions, signed decisions, CAPA effectiveness checks, risk-file input, the inspector summary, and the audit trail.
See the roadmapStrategy, requirements, design controls, regulatory, clinical, manufacturing operations, field actions and recalls, continuous monitoring, and retirement remain roadmap areas. AI assistance is switched on in a pilot once it is validated.
Planned as part of the broader MDARIX Medical Device Product Lifecycle Intelligence platform. This section is informational and does not represent available functionality.
Frame the intended use, target users, clinical problem, market need, business goals, and regulatory pathway before detailed design work begins.
Connect user needs, patient populations, care settings, clinical risks, and measurable outcomes so product requirements begin with a clear clinical purpose.
Establish functional, safety, performance, usability, software, security, and regulatory requirements with ownership, rationale, and verification intent.
Coordinate design outputs, interfaces, risk controls, configuration decisions, and revisions while preserving traceability from requirement to implementation.
Organize design inputs, outputs, reviews, verification, validation, change control, and approval evidence into a reviewable design history.
Bring test protocols, results, deviations, failures, corrective actions, and approval records together so verification status is inspectable and complete.
Maintain the relationship between clinical evaluation, intended use, benefit-risk reasoning, usability evidence, and the product configuration under review.
Draft regulatory narratives from the evidence of the exact product version, with every statement citing its source. MDARIX drafts for your team to review and approve; it does not submit anything to a regulator.
Relate manufacturing processes, suppliers, components, lots, deviations, inspections, and release records back to the approved product configuration.
Identify affected versions, lots, markets, customers, risk rationale, communications, execution status, and evidence for a controlled field action.
Track trends, thresholds, open unknowns, supplier performance, complaint patterns, and changes that may alter the product risk picture.
Preserve the final configuration, support obligations, residual risks, records, customer impact, and regulatory responsibilities through product retirement.
Start with exports from your quality, product and supplier systems. Your systems of record stay where they are.