Medical devices + IVDs
Current focusEngineering baseline: US, EU, Great Britain/Northern Ireland, Australia, Brazil, Canada, Japan, and MDSAP. The 250-jurisdiction expansion register remains claim-gated.
View solution Investigation Intelligence · Therapeutic biotech previewDetect quality risk earlier.
Detect quality risk earlier.
Investigate with evidence.
Stay inspection-ready.
QMS Studio connects quality signals, controlled evidence, human decisions, and regulatory change across medical devices, IVDs, and an honestly scoped therapeutic-biotech expansion.
Interactive demonstration · Synthetic records · Human approval required
Medical devices + IVDsCurrent product focusTherapeutic biotechExpansion previewHuman-governed AINo autonomous closure250 jurisdiction gatesEvery market claim-blocked
Investigation IntelligenceThe system finds the pattern.
The system finds the pattern.
Your quality team decides.
Bring complaints, deviations, OOS/OOT results, lots, suppliers, equipment, methods, analysts, controlled procedures, and prior CAPAs into one cited evidence trail.
CMP-2026-0142 · Synthetic record
AI draft · cited · human verification requiredUnexpected false-negative trend across three sites
Ready to scan permission-filtered synthetic records
Evidence before answers.
The analysis stays empty until governed retrieval runs. No uncited conclusion is filled in.
AI assembles evidence and drafts hypotheses. It cannot determine root cause, reportability, batch disposition, CAPA approval, effectiveness, or closure.
AskInvestigateProveHuman decision
Purpose-built operating models
Start with the quality system you actually operate.
One governed evidence layer, with controls and terminology that stay honest about each domain’s maturity.
Therapeutic biotech
Expansion previewA separate product concept for deviations, OOS/OOT, batch impact, QA disposition, validation, quality agreements, lot genealogy, and PQR/APQR—not part of the current device/IVD PRD or corpus.
View solutionRegulated laboratories
Workflow blueprintQC/PT failure, instrument, reagent, analyst evidence, and controlled corrective action. CLIA operations remain a separate compliance pack.
View solutionCRO + CDMO
Workflow blueprintMulti-client quality events, affected sponsors, quality-agreement obligations, delegated actions, and outsourced-manufacturing oversight.
View solutionTherapeutic biotech · expansion preview
From development signal to controlled QA disposition.
This is a separate product concept outside the current medical-device and IVD PRD and regulatory corpus. Production requirements, configuration, validation, integration, and qualified regulatory assessment remain required.
- 01Development
- 02Tech transfer
- 03Manufacturing
- 04Quality-unit disposition
- 05Continual improvement
A connected quality model
Product / programDrug substanceDrug product / biologicSiteBatch / lotMaterialMethod / specificationEquipmentContractorRegulatory commitment
Representative concept basis
21 CFR Parts 210/211 and applicable Parts 600–680 · 21 CFR Part 11 · EU GMP Parts I/II and selected annexes · ICH Q7–Q10/Q12.
Concept-mapped—not part of the device/IVD baseline, certified, validated, or claimed as pharmaceutical-GMP coverage.
Regulatory horizon
Upcoming changes, translated into quality work.
Every item carries an exact date or watch-only status, an applicability boundary, an evidence gap, and a human decision gate.
Devices + IVDsBinding and applicability-assessment dates
EUDAMED legacy-device registration
Inventory, identifier, actor, and evidence-completeness work for applicable legacy devices.
EU Product Liability Directive transposition
Software-product evidence preservation, disclosure readiness, and defensible decision records.
EU AI Act high-risk applicability assessment
Provider/deployer role, intended use, Annex I product link, model inventory, and human oversight.
Therapeutic biotechExpansion horizon
Revised EU GMP Annex 19 applies
Reference and retention sample inventories, quantities, storage, test capability, and written agreements.
EU SoHO Regulation generally applies
Applicability branching for upstream donor, testing, collection, release, and relevant ATMP supply chains.
EU GMP Chapter 4 / Annex 11 / Annex 22 drafts
Scenario planning for data integrity, cloud/supplier controls, computerized systems, and AI governance.
Official sources: EUDAMED rollout · Product Liability Directive · AI Omnibus · EU GMP Annex 19 · EU SoHO Regulation · EU GMP draft consultation.
Medical-device + IVD requirements baseline
See what each market requires.
The PRD includes the generated requirements. Before launch in a market, confirm the local sources, configure the controls, validate the deployment, and obtain qualified approval.
- Requirements
- 1,027 engineering PRD
- Modules
- 111 control domains
- Catalog records
- 1,055 official-source inventory
- Verified files
- 875 acquired + hash checked
- Searchable sources
- 844 strict extraction passed
- Jurisdiction gates
- 250 country + territory entries
- Transfer failures
- 180 remediation required
- Scan-ready
- No claim-blocked baseline
See the evidence country by country.
Explore global coverage Search the 250-entry register, inspect local medical-device and IVD instruments, separate vendor-sale obligations, and see exactly where acquisition or discovery remains incomplete.
Trust & validation roadmap
Enterprise trust, without vague compliance claims.
The demo shows the control model. The Trust Center separates demonstrated patterns, production requirements, and independent assurance.
Human-governed AIDemonstrated in synthetic workflowsDemonstrated
AI provenance + evidence linksVisible source versions and decision stateDemonstrated
Part 11 / regulated-record control designCustomer testing and approval requiredSpecified
HIPAA-enabled deployment profile12 requirements specified; BAA and production evidence required before PHISpecified
SOC 2 Type II / ISO 27001No report or certification claimedPlanned
Public demo dataNo confidential data, personal data, PHI, or regulated recordsSynthetic only
See the evidence pathBring one quality workflow.
Bring one quality workflow.
See how it becomes governed evidence.
Map a complaint, deviation, OOS, supplier issue, or regulatory change against QMS Studio.