Lotivara AI orchestrates the complete OEM contract manufacturing lifecycle. From drawing intake and IQ/OQ/PQ validation to raw material genealogy, in-process CTQ metrology, and radiation sterilization reconciliation. Ensure uncompromised 21 CFR Part 11 and ISO 13485 audit readiness, eliminate batch release delays, and release device lots with verified evidence.
Connect medical device manufacturing throughput with NCR aging, batch traveler completeness, and authorized lot release status. Spot delivery exposures, quarantine holds, and sterilization delays before they impact OEM commitments.
96.5% First-Pass Yield tracked across cleanroom work orders, with statistical alerts on process drift.
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Lotivara AI connects engineering, execution, quality, and financial settlement into a single auditable foundation. Each module manages a critical stage in medical device contract manufacturing, eliminating paper batch traveler risks and release delays.
Evaluate 2D prints, BOM revisions, and technical specs with automated discrepancy detection. Lotivara calculates tooling amortization, cleanroom labor, and qualification NRE to deliver auditable, OEM-ready quotes in minutes.
Define multi-stage operation sequences from precision tube cutting to cleanroom packaging. Map critical-to-quality (CTQ) checkpoints against PFMEA risk matrices and track IQ/OQ/PQ protocol readiness before production release.
Ingest resin, polymer, and metallic component receipts with automated Certificate of Analysis parsing. Verify dimensional tolerances and ISO 10993 biocompatibility against device specs, isolating unverified lots before cleanroom intake.
Enforce digital line clearances, qualified operator sign-offs, and machine parameters across work centers. Capture live telemetry and in-process metrology into validated eDHR travelers, instantly flagging equipment alarms and scrap drift.
Record optical CMM metrology, leak decay testing, and packaging seal integrity against validated acceptance limits. Failed tests automatically quarantine affected device lots, triggering root-cause investigations, MRB reviews, and CAPA workflows.
Eliminate batch release lag with an automated release blocker engine that verifies traveler sign-offs, metrology reports, and sterilization dosimetry. Authorize lot release via 21 CFR Part 11 electronic signatures to generate customer CoAs.
Ensure only QA-authorized device lots trigger shipping manifests, Certificates of Conformity, and commercial invoicing. Automatically reconcile delivered quantities against OEM purchase orders while capturing tooling NRE and validation protocol expenses.
Surgical implant tracking and component serialization held to micro-tolerances with automated material traceability.
Qualified cleanroom engineers conduct continuous line clearance and automated dimensional checks directly into eDHR.
Robotic sub-assembly and catheter fabrication tracked with step-by-step traveler verification and torque lockouts.
Generic ERPs and paper-heavy MES tools trap data across isolated binders. Lotivara AI orchestrates intelligence across every stage—from drawing extraction to cleanroom telemetry and authorized lot release.
Siloed spreadsheets, manual paper binders, and slow post-manufacturing audits.
Release delays and compliance risk.
Multi-modal vision models extract micro-tolerances, critical-to-quality dimensions, and revision notes from OEM 2D drawings and 3D CAD files.
Automated semantic comparison flags mismatched tolerances, altered resin callouts, or missing packaging specs across ECO releases.
Document intelligence maps incoming raw material test values—tensile strength, melt index, biocompatibility—against validated acceptance criteria.
High-speed telemetry models monitor extrusion heating zones, ultrasonic weld energy curves, and cleanroom pressures against statistical control limits.
Statistical quality algorithms evaluate optical coordinate measuring data, compute real-time Cpk, and trigger automated quarantine containment.
Cross-checks radiation dosimetry, packaging seal integrity, and eDHR signatures to identify release blockers before QA authorized sign-off.
Note: Model names and marks are the property of their owners and appear here to say which APIs a workflow step can be routed to. No endorsement or partnership is implied.
Medical device contract manufacturers are answerable to FDA investigators, notified bodies, and OEM auditors. Lotivara AI is engineered to the standards below, ensuring electronic signatures, process validations, and lot genealogy are audit-ready from day one.
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.
Calibrated inspection and cleanroom monitoring hardware seamlessly interfaces with Lotivara AI. Stream laser measurements, airborne particle telemetry, and CMM dimensions directly into your electronic batch travelers without manual transcription.
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.
Explore how Lotivara AI orchestrates your production, quality, and lot release workflows. Predictable subscription pricing designed for OEM contract manufacturers, with no hidden per-operator penalties.
Starting at $200/mo — every module, plant-wide deployment, billed monthly.
Note: AI API usage is charged separately. Clients must recharge their AI credit balance based on their usage.
Note: Nothing is locked in. Move at the pace your operations move — change or pause whenever it suits you.
A structured deployment that gets your manufacturing operations live with validated IQ/OQ/PQ evidence. We import your part numbers, configure your Device Master Records (DMRs), integrate your metrology instruments, and ensure complete 21 CFR Part 11 compliance before your first production batch.
Two ways to run Lotivara AI — same platform, same monthly subscription. Only the onboarding may differ by your requirements.
Runs in Nestack's dedicated GxP-ready cloud. We handle infrastructure, SOC2 Type II security, and continuous updates so your engineering and quality teams log in and start executing.
The same Lotivara platform deployed inside your own validated infrastructure — private cloud, VPC, or on-premise cluster. Meets OEM non-disclosure agreements, ITAR restrictions, and internal 21 CFR Part 11 software validation mandates.
Our subscription starts at flat transparent pricing with all 8 operational modules included. We never penalize your facility for cleanroom headcount growth—you receive unlimited shop-floor operator and line inspector accounts. Crucially, multi-tenant OEM customer guest portals are included at zero extra cost, allowing your medical device clients to review lot status, inspect batch records, and download CoCs without forcing you into expensive enterprise seat tiers.
Yes. Most contract manufacturers begin with one pilot production line or a single high-mix device family (such as an orthopedic implant or catheter extrusion cell). You can validate, train operators, and quantify lot release acceleration on that line first, then expand to additional facilities or product families on your own schedule with zero migration penalties or lock-in.
You receive a complete, audit-ready Computer Software Assurance (CSA) validation package—including pre-executed IQ/OQ protocols, Traceability Matrix, Risk Assessment (GAMP 5), and 21 CFR Part 11 compliance certification. During an FDA inspection or Notified Body audit, you can hand auditors immutable, timestamped electronic records and export complete Device History Records (DHRs) in seconds, backed by our regulatory audit support guarantee.
We treat OEM customer confidentiality as mission-critical. Every OEM client's CAD models, bill of materials, and batch records reside in cryptographically segregated tenants with role-based GxP access controls. For defense-critical medical contracts or strict customer security agreements, we offer dedicated single-tenant VPC and on-premise deployment options with full SOC 2 Type II, HIPAA, and ITAR compliance.
Contract manufacturers typically achieve full payback within 60 to 90 days. The primary returns come from three immediate operational improvements: cutting finished-lot release quarantine from 5–7 days down to zero hours (accelerating invoicing and cash collection), reducing scrap and rework by 38% via early SPC drift alerts, and speeding complex RFQ turnaround from 3 weeks to 48 hours to win more high-margin OEM programs.
You do not need to rip and replace any existing systems. Lotivara AI integrates directly alongside your current ERP (SAP, NetSuite, Epicor) and QMS/PLM (MasterControl, Veeva, Greenlight Guru). It specifically closes the costly manual gap those tools leave behind: turning paper batch travelers, CMM inspection printouts, and supplier CoAs into an automated, validated path to authorized lot release.
A typical cleanroom deployment takes 2 to 4 weeks. Our dedicated GxP onboarding team handles drawing template parsing, routing imports, and equipment API hooks (Zeiss, Keyence, Mitutoyo). Your manufacturing and quality engineers only need to spend approximately 4 to 6 total hours reviewing the validation package and approving master routing templates.
Contract manufacturing operates around the clock. All active subscriptions include 24/7 GxP technical support with a guaranteed 15-minute response SLA for critical cleanroom execution blockers, plus a dedicated Quality Systems Engineer who assists with customer audits, annual revalidation reviews, and system upgrades at no extra cost.
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Pinned to ISO 13485 & 21 CFR 820 GxP playbooks, and connected through the documented APIs of the CAD, PLM, ERP, and MES systems your cleanroom already runs on.
discover nestack agentsNote: Tool names and marks belong to their respective owners. No endorsement or partnership implied. Integration availability depends on your existing systems, licences, API access and implementation scope.
