DruqelvixAI
Book Demo
Engineers and technicians collaborating on cleanroom medical device assembly
medical devices & diagnostics operations platform

The Unified AI Operations Platform For Medical Devices & Diagnostics.

book a walk-throughsee how it works

Druqelvix AI is an enterprise operations platform connecting every operational stage of medical device and diagnostics manufacturing. It unifies Product Design controls, Supplier Inventory readiness, Equipment Maintenance, Manufacturing execution, Quality & Compliance release, Distribution fulfillment, and Customer Support into one real-time command center—eliminating paperwork bottlenecks, preventing costly production downtime, and keeping every department audit-ready.

VP of Quality & RegulatoryManufacturing Operations LeadDesign Assurance EngineerBuilt for device OEMs & IVD manufacturers
the dashboard moduleexecutive operational command center

Executive Operations Command Center For Total Clarity.

The Dashboard is the operational command center for medical device manufacturing. It unifies live production yield, machine health, material readiness, and quality disposition into one real-time view. Instead of chasing paper and spreadsheets, teams instantly spot bottlenecks, prioritize risks, and keep operations audit-ready.

Druqelvix AI — Executive Operations Command Center dashboard
4×
faster batch & lot release
from raw material receipt to authorized eDHR disposition
12+ hrs
recovered daily per line
eliminated across manual line clearance, charting & shift handoffs
< 90s
AI extraction & CoA parsing
supplier inspection certs and machine telemetry parsed into eDHR
99.4%
audit & compliance accuracy
zero documentation gaps across FDA QMSR, ISO 13485 & MDR reviews
the complete operational lifecycle

Connected operational modules, woven into one.

Druqelvix AI connects every stage of medical device and diagnostics manufacturing into an integrated, compliant ecosystem. From initial design inputs and raw material qualification to cleanroom execution, statistical quality control, fulfillment, and postmarket service, every module shares unified traceability and audit-ready data.

Druqelvix AI — Product Design module
Product Design01 / 07

Design Controls & Verification Traceability

The Product Design module connects engineering specifications directly to manufacturing and quality workflows. AI automatically maps user needs to CAD models, risk matrices (ISO 14971), and verification test protocols. When revisions occur, it flags impacted work instructions and regulatory files, ensuring only approved designs enter production.

design controlsAI requirement tracingISO 14971 riskdesign transfer
Druqelvix AI — Inventory & Supply module
Inventory & Supply02 / 07

Supplier Qualification & Material Readiness

The Inventory & Supply module ensures only verified, compliant raw materials enter cleanroom production. AI instantly extracts and verifies supplier Certificates of Analysis (CoAs) against approved tolerance limits and shelf-life requirements. Defective or unapproved materials are blocked before assembly, eliminating scrap and unexpected line halts.

automated CoA extractionAI tolerance checkASL qualificationshelf-life tracking
Druqelvix AI — Equipment Maintenance module
Equipment Maintenance03 / 07

Asset Condition & Predictive Health

The Equipment Maintenance module prevents unexpected machine breakdowns across cleanroom production cells. AI models analyze continuous telemetry—including vibration velocity and motor temperatures—to predict mechanical failures before they happen. Automated interlocks lock out uncalibrated tooling, protecting product quality.

predictive AI telemetryvibration monitoringcalibration lockssmart PM alerts
Druqelvix AI — Manufacturing module
Manufacturing04 / 07

Controlled Cleanroom Execution & eDHR

The Manufacturing module guides cleanroom technicians through controlled work orders with interactive digital instructions. Operators scan component barcodes and log torque, temperature, and dimensions directly into electronic Device History Records (eDHR). AI monitors process drift in real time, alerting leads before defects spread.

electronic DHRAI drift detectiondigital work instructionsbarcode genealogy
Druqelvix AI — Quality & Compliance module
Quality & Compliance05 / 07

In-Process Inspection & Lot Disposition

The Quality & Compliance module automates inspection data collection, statistical process control, and lot release. AI calculates real-time process capability (Cp/Cpk), assists with nonconformance root-cause investigations, and drafts CAPA records. Quality managers review pre-verified digital evidence and release lots with complete audit readiness.

automated SPC & CpkAI root-cause triageFDA QMSR & ISO 13485lot release gate
Druqelvix AI — Distribution module
Distribution06 / 07

Release Verification & UDI Serialization

The Distribution module guarantees that only released, fully compliant medical devices ship to healthcare providers. AI verifies quality clearances and sterilization certificates before warehouse dispatch orders can be printed. By validating Unique Device Identification (UDI) barcodes, it maintains end-to-end traceability to customer sites.

UDI barcode validationautomated release checkcold-chain telemetryfulfillment tracking
Druqelvix AI — Customer Support module
Customer Support07 / 07

Field Service Triage & Postmarket Vigilance

The Customer Support module manages installed devices, field service calls, and customer complaints. AI triages incoming tickets, retrieves relevant technical manuals, and groups recurring failure trends for engineering fixes. It also automatically flags adverse-event candidates, ensuring timely compliance with FDA and EU vigilance rules.

AI complaint triageadverse-event alertsIFU retrievalpostmarket surveillance
how it works

A seamless workflow, from design to postmarket. 

Medical device and diagnostics manufacturing requires unbroken technical traceability across engineering requirements, supplier certificates, cleanroom equipment, production execution, and field performance.Druqelvix AI connects every stage into an intuitive, compliant workflow—ensuring complete evidence lineage while keeping qualified personnel in total control.

  1. step one

    Product Design Transfer & Supplier Material Readiness

    Engineering teams lock device requirements, CAD specifications, and ISO 14971 risk controls into the Device Master Record (DMR). When raw components arrive, the system automatically reads supplier Certificates of Analysis (CoAs), checks critical tolerances against approved limits, and marks materials production-ready—ensuring uninspected materials never reach the assembly line.

  2. step two

    Controlled Manufacturing & Asset Readiness

    Before production begins, equipment sensors verify calibration status and healthy vibration thresholds. On the cleanroom floor, technicians follow approved digital work instructions, verify component lot barcodes, and log torque, temperature, and dimensional measurements directly into the electronic Device History Record (eDHR).

  3. step three

    Quality Disposition, Traceable Distribution & Postmarket Service

    Quality inspectors evaluate real-time statistical process control charts (Cp/Cpk) and assemble digital release packages for human authorization. Released products are tracked through UDI serialization to customer sites, while customer service cases and field complaints loop directly back into CAPA and engineering continuous improvement.

Controlled cleanroom medical device precision assembly and quality inspection
From initial product design inputs to field installation and postmarket surveillance,Druqelvix AI keeps your entire operation connected, compliant, and audit-ready.
Traditional SaaS vs Druqelvix AI

Don’t settle for the AI your software chose.

Most platforms ship one generic model and you work inside its limits. Druqelvix AI puts an orchestration layer between regulated documents, telemetry feeds, and specialized models, so every step of a device’s lifecycle runs on the intelligence best suited for regulated execution.

Traditional SaaS
Built-in
AI

One model, one pass, and no step you can point somewhere else.

You work within its limits.

Druqelvix AI · Routed MedTech flow
  • 01

    Read incoming supplier Certificates of Analysis (CoA)

    Layout-aware OCR extracts multi-column chemical assays, tolerance limits, and heat lot numbers from vendor PDFs without flattening tables.

    MistralDocument AI / OCR
  • 02

    Classify engineering drawings & inspection sheets

    A fine-tuned classifier separates CAD specs, IQ/OQ/PQ protocols, and dimensional inspection sheets page by page at high throughput.

    Hugging FaceInference Providers
  • 03

    Parse entire Device Master Record (DMR) in one pass

    Long context holds the complete multi-assembly BOM, drawings, and risk management file so design changes maintain complete traceability.

    GeminiGemini API
  • 04

    Extract into 21 CFR Part 11 / QMSR compliant schema

    Constrained decoding against strict ISO 13485 and QMSR schemas prevents malformed entries from landing in your enterprise ERP or MES.

    OpenAIResponses API
  • 05

    Draft nonconformance & CAPA root-cause analysis

    Structures 5-Whys and Ishikawa cause-and-effect hypotheses citing exact machine telemetry lines and operator observation logs.

    ClaudeAnthropic Messages API
  • 06

    Calculate SPC capability & evaluate Western Electric rules

    Deterministic statistical computation calculates Cp, Cpk, and Nelson/Western Electric rule violations across all inspection dimensions.

    DeepSeekDeterministic SPC Engine
  • 07

    Match failure modes to ISO 14971 hazard categories

    Fuzzy policy matching is a retrieval problem — embeddings and semantic rerankers correlate field complaints with risk management hazard tables.

    CohereRerank + Embed
  • 08

    Mask proprietary IP & cleanroom telemetry before export

    A small open-weight model runs inside your private VPC, so sensitive device designs and proprietary manufacturing parameters are protected.

    LlamaSelf-hosted in your VPC
One validated Device History Record (DHR)240+ verified trace points · 99.2% mean confidence · 0 unverified releases

Note: Model and product names are trademarks of their respective owners, used here to describe what runs where. Routing is configurable per workflow — no endorsement or partnership is implied.

Compliance

Built to the rules you are already held to

Medical device and diagnostics manufacturing runs on records that have to be unequivocally validated. Druqelvix AI is designed around current global regulatory frameworks — here is what it supports, and how it governs your operations.

  • 21 CFR Part 820 (QMSR)

    FDA Quality Management System Regulation

    Supports medical device quality documentation, design traceability, manufacturing records, supplier quality evidence, and CAPA workflows aligned with applicable QMSR requirements.

  • ISO 13485:2016

    Medical Devices — Quality Management Systems

    Helps teams organize controlled quality records, manage design and production traceability, track nonconformances, and prepare supporting evidence for quality-system reviews.

  • EU MDR & IVDR

    EU Medical Device & IVD Regulations

    Supports organization and review of technical documentation, regulatory evidence, device traceability, and postmarket records for applicable EU medical device and IVD requirements.

Note: These are standards the platform is built to support inside your workflows — obligations that fall on you as the licensee. They are not certifications held by us, and support in the product is not a substitute for your own counsel or compliance officer.

Add-ons

Add the hardware your workflow needs.

Druqelvix AI interfaces seamlessly with validated third-party industrial peripherals, sensor gateways, and cleanroom metrology instruments. Each device bridges physical manufacturing evidence directly into the governing compliance and execution modules.

  • Traceability & Serialization

    Industrial 2D DPM & UDI Barcode Scanner

    Ruggedized high-density optical imager engineered for direct-part-mark (DPM) verification across surgical stainless steel, titanium implants, diagnostic cassettes, and sterile Tyvek packaging.

  • Metrology & Statistical Process Control

    Wireless Digital Metrology Interface Hub

    Multi-channel wireless data collector and serial bridge pairing with digital micrometers, depth gauges, bore indicators, and digital torque wrenches for regulated dimensional inspection.

  • Predictive Equipment Health

    Industrial IoT Triaxial Vibration & Temp Sensor

    Cleanroom-grade stud-mounted triaxial vibration and surface temperature telemetry sensor designed for continuous condition monitoring across high-speed tooling, presses, and spindle assemblies.

  • Controlled Environments

    Cleanroom Differential Pressure & Environmental Transmitter

    Wall-mount stainless transmitter monitoring differential room pressure (Pa), airborne particulate levels, relative humidity (%RH), and ambient temperature for ISO Class 7/8 manufacturing suites.

Note: Hardware, installation, and integration are not included in the standard subscription. Additional charges apply based on the hardware selected, integration modules required, and implementation scope.

Connectivity

Your whole stack, connected.

Oracle Cloud ERP, Veeva Vault QMS, Salesforce Service Cloud, Snowflake, and AWS Industrial IoT — the systems your medical device enterprise already runs on. 24 integrations across engineering PLM, manufacturing MES, quality eQMS, and postmarket service, reading authentic public APIs and industrial OPC UA protocols.

Oracle Cloud ERPVeeva Vault QMSSalesforce Service CloudDocuSign 21 CFR Part 11AWS Industrial IoTMicrosoft Teams HuddlesSlack Alarm WebhooksSnowflake Quality LakeTableau Manufacturing BIPower BI SPC DashboardsJira CAPA TrackingLinear Engineering TasksOracle Cloud ERPVeeva Vault QMSSalesforce Service CloudDocuSign 21 CFR Part 11AWS Industrial IoTMicrosoft Teams HuddlesSlack Alarm WebhooksSnowflake Quality LakeTableau Manufacturing BIPower BI SPC DashboardsJira CAPA TrackingLinear Engineering TasksOracle Cloud ERPVeeva Vault QMSSalesforce Service CloudDocuSign 21 CFR Part 11AWS Industrial IoTMicrosoft Teams HuddlesSlack Alarm WebhooksSnowflake Quality LakeTableau Manufacturing BIPower BI SPC DashboardsJira CAPA TrackingLinear Engineering Tasks
Azure Industrial EdgeGoogle BigQuery TelemetryDatabricks Manufacturing AITwilio Critical Line AlertsSendGrid Audit NotificationsHubSpot Supplier CRMZapier Factory AutomationOracle Supply ChainVeeva Regulatory SubmissionsDocuSign Validation VaultAWS SiteWise TelemetryPower BI OEE MetricsAzure Industrial EdgeGoogle BigQuery TelemetryDatabricks Manufacturing AITwilio Critical Line AlertsSendGrid Audit NotificationsHubSpot Supplier CRMZapier Factory AutomationOracle Supply ChainVeeva Regulatory SubmissionsDocuSign Validation VaultAWS SiteWise TelemetryPower BI OEE MetricsAzure Industrial EdgeGoogle BigQuery TelemetryDatabricks Manufacturing AITwilio Critical Line AlertsSendGrid Audit NotificationsHubSpot Supplier CRMZapier Factory AutomationOracle Supply ChainVeeva Regulatory SubmissionsDocuSign Validation VaultAWS SiteWise TelemetryPower BI OEE Metrics

Note: Tool names and marks belong to their respective owners. No endorsement or partnership implied.

our prices

Predictable support for regulated manufacturing.

A first conversation is often just that — a conversation. From there it is one plan at one price, whichever stages of medical device operations you hand to Druqelvix AI. No per-line math, no complex tiers to decode.

the complete platform
$200/mo

Starting at $200/mo — all core operational modules, unlimited audit-trail records, billed monthly.

  • dashboard command center
  • product design
  • inventory and supply
  • equipment maintenance
  • manufacturing
  • quality & compliance
  • distribution
  • customer support
Know more

Nothing is locked in. Move at the pace your site validation requires — scale or pause whenever it suits you.

Note: AI API usage is charged separately. Clients must recharge their AI credit balance based on their usage.

onboarding

What your onboarding fee covers

A structured implementation that gets your manufacturing site fully validated and operational before your first billing cycle — we import your Device Master Records (DMR), configure supplier specification bands, connect equipment telemetry gateways, and validate every Druqelvix AI module to your site SOPs.

Each fee is a starting point marked with a “+”. We scope the final onboarding once we understand your cleanroom layout, equipment interfaces, ERP/PLM integrations, data migration volume, compliance requirements, and deployment model — so you only pay for the validation work your facility actually needs.

Essential

$1,000+one-time
  • Kickoff call with VP Quality, Plant Manager and Manufacturing Engineering leads to map production cells, cleanrooms, and shifts
  • Druqelvix AI workspace provisioned with your facility branding, site configurations, and admin accounts
  • Import of approved Device Master Record (DMR) routing and BOM structures
  • Manufacturing Execution configured to approved work instructions and component scan gates
  • Supplier Certificate of Analysis (CoA) intake templates set up for top 10 raw materials
  • Roles and permissions configured for QA/QC inspectors, supervisors, and release authorities
  • Validation Starter Pack with IQ/OQ templates and user requirement traceability matrices
  • Live-readiness dry-run and an onboarding handbook before your first billing cycle

Plus

most chosen
$2,500+one-time

Everything in Essential, plus:

  • Guided migration of historical DHR records, inspection histories, and open CAPA records, validated on import
  • Two integrations wired up — your ERP (SAP/NetSuite) or eQMS (Veeva Vault/MasterControl)
  • Document processing trained on custom supplier certificates, material CoCs, and mill test reports
  • Statistical Process Control (SPC) thresholds and machine alert bands tuned to engineering specifications
  • Live training sessions for process engineers, quality inspectors, and floor supervisors, with recordings to keep
  • A dedicated validation and manufacturing specialist through go-live

Enterprise

$5,000+one-time

Everything in Plus, plus:

  • Tailored rollout across multiple global manufacturing plants and contract manufacturing partners
  • Bespoke integrations with MES, SCADA/PLC OPC UA gateways, SSO, and 21 CFR Part 11 audit log archiving
  • Bulk records migration with de-duplication, computerized data reconciliation, and legacy DHR digitization
  • Quality & Compliance workflows and investigation templates aligned to FDA QMSR and EU MDR/IVDR requirements
  • Role-based training tracks and administrator enablement for global quality and regulatory teams
  • Named onboarding director with a committed go-live date and post-launch regulatory audit defense support
how it runs

Two ways to run Druqelvix AI — same platform, same subscription rate. Only the onboarding may differ by your requirements.

Cloud (SaaS)

Runs in Nestack's SOC 2 Type II and ISO 27001 managed cloud with tenant isolation — the fastest way to operationalize your facility. We handle infrastructure, automated backups, and software updates so your team logs in and starts manufacturing.

Private / self-hosted / VPC

The same Druqelvix AI platform deployed inside your own validated infrastructure — your private AWS/Azure VPC or on-premise server cluster — for manufacturers with strict data sovereignty, ITAR, or proprietary device IP requirements. Your data never leaves your environment, and the subscription rate stays the same.

Sister platform — Nestack Agent Care

Your Medical Devices AI agents, run like production systems.

Telemetry, evaluations, guardrails, human review, and a crew on call when one of them starts drifting at 3am.

Explore Medical Devices & Diagnostics(opens nestackagents.com in a new tab)
  • 206Failure modes
  • 89Sev-1 failure modes
  • 990+Baseline eval cases
  • 24/7Agent monitoring

Pinned to the Medical Devices & Diagnostics agent playbook — not a generic agent checklist.

common questions

Your questions. Answered plainly.

Deploying AI into a regulated manufacturing and quality environment raises serious questions. These are the ones VP of Operations and Quality Directors ask us first.

About Druqelvix AI

Druqelvix AI is designed for medical device and diagnostics manufacturers with different operational needs. Subscription pricing can be tailored to the modules required, number of users, manufacturing sites, and integration requirements. You can start with the operational areas that matter most to your business and discuss expansion as your needs grow. Contact our team for a quote based on your manufacturing environment, quality workflows, and implementation scope.

Didn’t find your answer? Send us a message — we’ll respond with care and clarity.