QAssure.ai
As regulatory complexity continues to grow, MedTech organizations need a faster, more intelligent way to manage quality and compliance. LTTS’ QAssure.ai is an AI-native platform that turns Quality Assurance and Regulatory Affairs into one digital thread – from post-market signal to audit-ready proof.
Predictable compliance. Measurable ROI.
Compliance Demands Are Growing Faster Than QARA Teams Can Keep Up
Signals, certificates, literature, and regulatory updates are all accelerating. Yet, the teams assessing them still work document by document, often by hand.
Signals Outpace Assessment
Complaints, vigilance alerts, and real-world data are exploding, but impact assessment stays slow, manual, and inconsistent
Manual Compliance Does Not Scale
Expert-driven document reviews slow change cycles and consume valuable QARA resources that should be focused on higher-value decisions
Every Market Demands Different Proof
FDA QMSR, EU MDR, and EUDAMED each require different evidence, compelling teams to repeatedly rebuild audit documentation
QARA Data Lives Everywhere
Evidence is fragmented across QMS, PLM, and document repositories, making audit readiness a last-minute scramble
The result: Your quality and regulatory experts spend more time searching for documents than protecting patients.
Six Modules, One Platform
Clinical Evaluation
Finds and screens published research, then drafts MDR-ready CER and PSUR reports. Experts review while the platform does the heavy lifting.
Signal Detection
Analyzes complaint, determines reportability, applies IMDRE codes, drafts investigation summaries, and monitors global regulatory updates that may affect your products.
Supplier Quality
Verifies supplier certificates against inspection plans – handwriting documents – flags discrepancies, drafts supplier communication, and screens materials for restricted substances such as PFAS.
Impact Assessment
Identifies the impact of regulatory changes, highlights documentation gaps, and generates remediation plan by reusing existing evidence whenever possible.
DHF Automate
Migrates legacy documents into compliant templates, compares versions with clear redlines, and highlights the rationale behind every change.
Audit OK
Maintains market-specific documentation completeness and generates audit-ready evidence packs on demand.
AI Features are Easy. A Closed Compliance Loop is Not.
Unlike a number of AI tools built to summarize documents, QAssure.ai works as a fully-capable closed compliance loop. The solution is:
Closed Loop, with Signal to Proof: One connected workflow takes a post-market signal through to updated documentation and audit-ready proof, with no need for juggling tools or handoffs
AI That Shows Its Work: Every suggestion comes with its sources and its reasoning, and nothing unexplained enters a regulated record
Built for Regulated Use: Your experts approve every output, with every action tracked, versioned, and traceable
Ready for Every Market: Checklists and validation rules tailored to each market, and not one-size-fits-all paperwork
Always Audit-Ready: Completeness is checked in real time, so that audits stop being fire drills
Track Record and Proof
LTTS works with the top 10 global MedTech OEMs, delivering QARA programs across Class IIb and Class III implantable devices, imaging systems, and patient monitoring solutions.
90% automation. 80% less certification effort.
12 weeks to 4 weeks
- Leading global MedTech OEM
- 100%+ literature coverage
- First-time-right
8 weeks to 2 weeks
- Global device manufacturer
- 20% more relevant studies found
Zero corrections
- Neuromodulation devices (Class III)
- 20+ CERs
- Top client rating
FDA-compliant in 3 months
- Medical device manufacturer
- No added resources
Across the QARA Lifecycle
From clinical evidence to post-market surveillance, the same platform is applied where documentation piles up.
What QAssure.ai does
Automates literature search, screening, data extraction, and MDR-compliant report generation, with expert review
Outcome
50–70% faster CER prep
What QAssure.ai does
Extracts entities from complaint narratives, determines reportability, generates investigation summaries, and applies IMDRF codes
Outcome
Faster intake-to-closure time
What QAssure.ai does
Verifies supplier certificates against RI plans (including handwritten data), flags discrepancies, and manages supplier follow-up
Outcome
80% less manual effort
What QAssure.ai does
Migrates legacy documents into compliant templates, compares versions with redlines, and closes documentation gaps
Outcome
Up to 80% less SME review effort
What QAssure.ai does
Monitors global regulators continuously, assesses applicability to your products and markets, and flags change triggers early
Outcome
Proactive, not reactive
What QAssure.ai does
Screens BOMs, drawings, MSDS, and supplier declarations against PFAS, REACH, RoHS and Prop 65 databases
Outcome
Screening completed in minutes
Built for MedTech - medical devices, IVD and SaMD, and extends to Pharma and Animal Health.
Regulatory knowledge codified in: EU MDR · MEDDEV Rev. 4 · FDA QMSR · ISO 13485 · ISO 14971 · IEC 62304 · IMDRF · EUDAMED.
Resources
QAssure.ai
LTTS' QAssure.ai turns complaints, signals, and regulations into audit-ready documentation - keeping QARA teams continuously ready with AI-guided workflows and expert oversight.
