Sovereign European Cloud
Headquartered in Luxembourg and hosted exclusively on EU-owned OVHcloud infrastructure. Your data stays under EU jurisdiction, outside the reach of the US CLOUD Act and aligned with Schrems II requirements.
XyReg: The Unified Workspace for Medical Device Teams
Developing medical devices shouldn't feel like a disconnected maze. Xyreg is the workspace where your vision comes to life, uniting product strategy, engineering, and compliance in one beautiful flow. It’s not just a collection of tools—it’s the ultimate destination to bring life-saving innovations from spark to success.
What
An AI-powered digital environment that replaces spreadsheets, shared drives, and disconnected QMS tools, with built-in document generation, smart advisory, and real-time Slack integration.
How
Xyreg Cortex AI works across three synchronized tracks, engineering, regulatory, and business, auto-generating documents, surfacing insights, and keeping your entire lifecycle in sync.
Why
Because safe, embedded AI eliminates consultant dependency, accelerates submissions, and gives regulators, investors, and your team one source of truth, not 15 tools duct-taped together.
From Chaos to Controlled Innovation
Developing medical devices today means navigating a disconnected maze of spreadsheets, emails, and generic tools. XYREG replaces this chaos with a single source of truth that unifies project management, quality management (QMS), and strategic financial planning.
Built by industry veterans with deep MedTech expertise, our workspace comes pre-loaded with document templates, audit templates, and regulatory requirements for global markets. You're not just getting software - you're getting a regulatory head-start.
Built for European MedTech Trust
Data sovereignty, certified infrastructure, and validation evidence built in from day one.
ISO 27001 Infrastructure
Running on hosting infrastructure certified to ISO/IEC 27001, ISO 27017 and ISO 27018. GDPR compliant, with safeguards designed for health data.
Validation in Minutes (ISO 80002-2)
Skip weeks of manual computer software validation. XyReg delivers pre-packaged, risk-based validation evidence following AAMI TIR80002-2 and ISO 13485 section 4.1.6 in minutes, not days.
Fragmented Tools vs. The XyReg Workspace
See why European MedTech teams are replacing disconnected QMS, PLM, and spreadsheet silos with one sovereign workspace.
| Feature / compliance indicator | Traditional eQMS & Disconnected Silos | XyReg (EU-native workspace) |
|---|---|---|
| Workspace Scope | Isolated document storage & CAPA forms only | Unified eQMS + PLM + Technical Dossier + Project Governance |
| Project & Financial Visibility | Zero project velocity or NPV tracking | Integrated milestone tracking, budget governance & NPV modeling |
| Data residency & jurisdiction | US cloud, exposed to the US CLOUD Act | 100% sovereign EU cloud (OVHcloud) |
| Data protection & privacy | Standard US privacy shields | Strict GDPR and Schrems II aligned |
| Infrastructure security | Varies by provider | ISO/IEC 27001 certified infrastructure |
| Software validation (CSV) | Weeks of manual protocol writing | Automated AAMI TIR80002-2 evidence in minutes |
| Design controls & traceability | Disconnected spreadsheets and documents | ISO 13485 section 7.3 integrated traceability engine |
Workspace Scope
Traditional eQMS & Disconnected Silos
Isolated document storage & CAPA forms onlyXyReg (EU-native workspace)
Unified eQMS + PLM + Technical Dossier + Project GovernanceProject & Financial Visibility
Traditional eQMS & Disconnected Silos
Zero project velocity or NPV trackingXyReg (EU-native workspace)
Integrated milestone tracking, budget governance & NPV modelingData residency & jurisdiction
Traditional eQMS & Disconnected Silos
US cloud, exposed to the US CLOUD ActXyReg (EU-native workspace)
100% sovereign EU cloud (OVHcloud)Data protection & privacy
Traditional eQMS & Disconnected Silos
Standard US privacy shieldsXyReg (EU-native workspace)
Strict GDPR and Schrems II alignedInfrastructure security
Traditional eQMS & Disconnected Silos
Varies by providerXyReg (EU-native workspace)
ISO/IEC 27001 certified infrastructureSoftware validation (CSV)
Traditional eQMS & Disconnected Silos
Weeks of manual protocol writingXyReg (EU-native workspace)
Automated AAMI TIR80002-2 evidence in minutesDesign controls & traceability
Traditional eQMS & Disconnected Silos
Disconnected spreadsheets and documentsXyReg (EU-native workspace)
ISO 13485 section 7.3 integrated traceability engineThe technical file, built from your product data.
Design controls, dossier and post-market evidence share one record. Change a specification once and every affected document follows, with the audit trail intact.
Strategic NPV & Financial Forecasting
Model what a launch is worth before committing. Device class, pathway, review timeline and testing cost feed the forecast, so the number moves when the regulatory picture does.
Role-Based Dashboards & KPIs
See what is actually blocking submission. RA sees file completeness by section, QA sees open CAPAs, the programme lead sees which milestone slipped and why.
Project Execution & Checklist Management
Every task rolls up to the programme view. A checklist item left open on design verification shows against the submission milestone it holds up.
Collaborative Reviews & Approvals
Reviews and approvals attach to the record itself. Comments, sign-offs and status changes stay with the document and its revision history.
Who is Xyreg For?
Designed for every stakeholder in the MedTech product lifecycle
Product Leaders & C-Suite
Own the strategy and the outcome. Steer the entire portfolio using a high-level dashboard with the financial and strategic KPIs that matter.
Project & Quality Managers
Demonstrate your team's impact. Report on progress using tactical KPIs like task completion rates and milestone adherence, showing how your execution drives success.
Medical Device Consultants
Manage your entire client portfolio from one hub. Use Xyreg to provide strategic advice, streamline submissions, and offer your clients unparalleled transparency and collaboration.
What Can You Build With Xyreg?
Explore the powerful modules that accelerate every stage of your MedTech lifecycle
Build
AI Requirements Specification
Generate compliant user needs & design inputs from natural language in minutes.
Available
Build
Draft Studio
One-click generation of technical files, SOPs, and submission documents.
Beta
Build
Risk Management (AI FMEA)
Automated hazard identification and risk mitigation per ISO 14971.
Available
Build
Software Lifecycle (IEC 62304)
Complete SaMD development with unit testing, bug tracking, and software BOM.
Coming Soon
Build
Usability Engineering (IEC 62366)
Human factors testing with formative, summative, and use error analysis.
Beta
Build
Labeling & IFU Generator
AI-drafted device labels and Instructions for Use with symbol library.
Coming Soon
Build
UDI Generator
Automated Unique Device Identifier creation compliant with FDA and EU MDR.
Beta
Build
BOM Manager
Bill of Materials tracking with component traceability and revision control.
Beta
Build
Design Traceability Matrix
Visual linking of requirements to design outputs, V&V, and risk controls.
Beta
Build
e-Sign Workflows
21 CFR Part 11 compliant electronic signatures for document approvals.
Coming Soon
Plan
Intelligent Gantt & Timeline
Visual project management with milestone tracking and critical path analysis.
Available
Plan
Task & Checklist Engine
Break down roadmaps into actionable tasks with status roll-ups to KPIs.
Beta
Plan
Resource Planner
Team allocation, workload balancing, and capacity forecasting.
Coming Soon
Plan
Venture Blueprint Builder
Structured framework for building investor-ready MedTech business cases.
Available
Plan
Market Sizing Tool
TAM, SAM, SOM analysis with target market segmentation.
Available
Regulatory
FDA Predicate Device Finder
AI-powered 510(k) predicate search with similarity scoring across FDA databases.
Beta
Regulatory
Clinical Evidence Builder
Literature search and CER drafting with evidence synthesis.
Coming Soon
Regulatory
EUDAMED Direct Connect
Automated data sync with EU medical device database.
Available
Regulatory
Technical File Assembler
Auto-generate submission-ready DHF/DMR documents from engineering data.
Coming Soon
Regulatory
Regulatory Intelligence
Real-time monitoring of FDA guidance, standards updates, and regulatory changes.
Coming Soon
Regulatory
Classification Wizard
Guided device classification for FDA, EU MDR, and global markets.
Available
Operate
Supplier Qualification Hub
Vendor scoring, audit scheduling, and certificate tracking.
Beta
Operate
CAPA & Root Cause
Corrective action workflows with structured root cause analysis.
Beta
Operate
Training Tracker (LMS)
Employee competency matrix with quiz generation and certification management.
Beta
Operate
Audit Management
Internal/external audit planning, finding tracking, and reports.
Beta
Operate
Change Control
Engineering change orders with impact analysis and approval workflows.
Beta
Operate
Document Control (DMS)
Version control, review cycles, and retention policies.
Beta
Operate
Non-Conformance (NCR)
Deviation tracking with investigation workflows and trending.
Coming Soon
Monitor
PMS & Vigilance
Auto-scan FDA MAUDE and EUDAMED for complaints and adverse events.
Beta
Monitor
Feedback Capture
Embed a feedback button on your website or inside your SaMD. Bugs, suggestions and adverse events — adverse events on the WHO user-feedback form — arrive as structured data in your PMS file.
Beta
Monitor
Complaint Handling
Log, trend and resolve incoming complaints, with routing to CAPA and full audit history.
Coming Soon
Monitor
Field Safety Actions
Recall management with affected unit tracking and customer notifications.
Coming Soon
Monitor
Periodic Safety Reports
Automated PSUR/PMSR generation with data aggregation.
Coming Soon
Strategy
Competitive Analysis Dashboard
Real-time competitor monitoring with automated market intelligence updates.
Beta
Strategy
Market Access & Reimbursement
CPT/DRG code analysis with coverage decision modeling and ASP forecasting.
Beta
Strategy
rNPV Valuation Dashboard
Phase-adjusted net present value tracking linked to regulatory milestones.
Beta
Strategy
Pricing Strategy Modeler
Global pricing scenarios with payer-specific reimbursement analysis.
Beta
Intelligence
Xyreg Cortex (AI)
Secure RAG and intelligent document analysis powered by Google Vertex AI.
Available
Intelligence
IP & Patent Manager
Freedom to Operate analysis with patent portfolio tracking.
Beta
Intelligence
KPI Watchtower
Role-based dashboards with real-time health indicators for executives.
Beta
Investor
Invest-Ready Score
Automated viability scoring calculated from regulatory and business data.
Available
Investor
Due Diligence Data Room
Secure document sharing with investor access controls.
Beta
Investor
Portfolio Health Dashboard
Real-time KPIs across sponsored startups in one view.
Beta
Find your plan
The unified workspace for medical device teams — helping you reach audit-ready compliance at any scale. Book a demo to discuss your needs and get personalized pricing.
100% EU-Sovereign Cloud Hosting (GDPR & ISO 27001 Compliant)
Essentials
The fastest path to audit-ready compliance for early-stage MedTech teams building their first device.
Pre-revenue device startups, university spin-outs, and grant-funded founders (<€500k raised).
Key capacity & usage
- 1 Active Device (Single Source of Truth)
- 3 Core Team Seats (+ unlimited read-only guest reviewers)
- 3 Regulatory Frameworks (Clause-by-clause gap analysis checklists)
- 2 Target Markets (e.g., US FDA & EU CE Mark)
- 1M Cortex AI Credits included (Pay-as-you-go booster packs available)
- 10 GB Secure Storage
Core capabilities
- Device PLM & Regulatory Identity: Native, audit-ready Product Master Record, providing dynamic market classification logic (e.g., EU MDR Class IIa, FDA Class II) and integrated Unique Device Identification (UDI) management.
- Core Design eQMS: ISO 13485 §7.3 design controls, immutable audit logs, and granular role delegation across the design team.
- Clause-by-Clause Gap Analysis: Live 2-way database synchronization against selected standards (e.g., Baseline Regulatory Check, ISO 13485:2016).
- Baseline Document Studio: 3 Core Design Controls (Design & Development Plan [DDP], Product Requirements Specification [PRS/URS], Device Description & Summary).
- Interactive Gantt & Stage-Gate Roadmap: Visual project schedule mapped to phase deliverables and design-freeze milestones.
- Starter Cortex AI: In-line checklist guidance, automated clause scoring, and requirement fill suggestions.
- Phase-End Design Review & Part 11 e-Signatures: Formal phase-end design reviews signed off with FDA 21 CFR Part 11 and EU Annex 11 compliant e-signatures, change control locks, and audit freeze modes.
- Platform Infrastructure: 100% EU-sovereign cloud hosting (GDPR & ISO 27001 compliant), revision tracking, and one-click PDF export of gap analysis reports.
- Support: Self-serve documentation and community knowledge base.
Plus
Comprehensive design controls and modular technical documentation for teams preparing active regulatory submissions.
Funded Seed and Series A MedTech companies actively compiling a 510(k), De Novo, or EU MDR Notified Body dossier.
Key capacity & usage
- Up to 3 Active Devices
- Up to 20 Core Team Seats (+ unlimited read-only guest reviewers)
- Up to 10 Regulatory Frameworks (e.g., FDA QMSR 2026, ISO 13485, ISO 14971, IEC 62304, IEC 62366-1)
- Up to 5 Target Markets (e.g., US, EU, UK, Canada, Australia)
- 5M Cortex AI Credits included (Discounted booster packs available)
- 50 GB Secure Storage
Core capabilities
Everything in Essentials, plus:
- Full Technical Dossier Studio: Complete catalog of ~45 modular controlled regulatory deliverables structured by submission chapter.
- 14 Compilable Deep Generators: Bespoke engines for submission-specific deliverables — Risk Management Plan (RMP), Requirements Traceability Matrix (RTM), Declaration of Conformity (DoC), Substantial Equivalence (SE) Predicate Matrix, and Classification Justification.
- 31 Pre-Structured Modular Skeletons: Turnkey technical templates auto-populated with data from your device SSOT.
- Market, Classification & Identification: Adds automated regulatory hub connections on top of Tier 1's base UDI identity — EUDAMED and FDA GUDID direct sync, plus notified body selector, auto-classification with per-market idiosyncrasies, and full multi-market code cross-mapping across FDA Product Codes/Regulation Numbers, EU EMDN and GMDN.
- Advanced Cortex AI: Predicate device matching, automated standard cross-referencing, and technical gap remediation drafting.
- Collaboration Workflows: Granular role-based access control (Author, Reviewer, Approver) with inline document commenting loops.
- Included Feedback Capture: Embeddable web widget with product/variant selectors, structured adverse-event intake (IMDRF/MedWatch aligned), and direct routing to management review and technical files.
- Support: Direct email support with standard business response times.
Most popular
Professional
Complete end-to-end Quality Management and continuous Post-Market operations in a unified workspace.
Commercialized medical device companies, clinical-stage manufacturers, and multi-line teams managing active products in market.
Key capacity & usage
- Up to 10 Active Devices
- Unlimited Team Seats (+ unlimited read-only guest reviewers)
- All Standard Regulatory Frameworks Included
- Up to 8 Target Markets
- 10M Cortex AI Credits included (Volume discount booster packs available)
- 200 GB Secure Storage
Core capabilities
Everything in Plus, plus:
- Post-Market & Production eQMS Suite: Comprehensive operational quality suite with integrated native modules for Corrective and Preventive Actions (CAPA), Non-Conformance Reports (NCR), Customer Complaints routing, and Approved Supplier List (ASL) qualification.
- Post-Market Surveillance (PMS) Engine: Workflows for Periodic Safety Update Reports (PSUR), Post-Market Clinical Follow-up (PMCF), and incident vigilance reporting.
- Reactive SSOT Diff Engine: Automated divergence alerts that flag downstream technical files and risk matrices whenever an upstream SSOT parameter changes.
- One-Click Submission Compiler: Compile the full 45-document technical binder into an audit-ready, structured ZIP and PDF/A export with automated Device Master Record (DMR) indices.
- In-Device SaMD Feedback & Auto-Vigilance: Embeddable SDK for in-app SaMD feedback, automated regulatory threshold flagging, real-time alerts for the PRRC, trend analysis across submissions, and automated export packs for vigilance filings.
- Support: Priority SLA support with expedited ticketing and technical guidance.
Enterprise
Tailored regulatory infrastructure, multi-device portfolio governance, and dedicated compliance oversight.
Established enterprise manufacturers, CDMO networks, multi-brand OEMs, and MedTech holding companies.
Key capacity & usage
- Unlimited Active Devices
- Unlimited Team Seats (+ unlimited read-only guest reviewers)
- All Standard & Custom Proprietary Frameworks
- All Global Target Markets
- 100M Cortex AI Credits included (Wholesale custom pricing on additional volume)
- Unlimited Secure Storage
Core capabilities
Everything in Professional, plus:
- Portfolio Multi-Device Governance: Cross-device component inheritance (edit shared components, sterile packaging, or power supplies once in SSOT, sync across multiple product dossiers).
- Custom Framework & Template Studio: Build, validate, and mandate internal corporate compliance checklists and SOP templates across subsidiaries.
- Auditor Inspection Portal: Dedicated secure, read-only external auditor review environment for live Notified Body or FDA inspections.
- Enterprise Integrations: REST API access for automated bi-directional synchronization with corporate PLM, ERP, and issue trackers (SAP, Arena, Windchill, Jira).
- PRRC as a Service Option: Optional bundling of certified Article 15 EU MDR/IVDR Person Responsible for Regulatory Compliance representation.
- Infrastructure Options: Single-tenant isolated database deployment options and custom security reviews.
- Enterprise Post-Market Orchestration: Multi-brand catalog routing and direct API streaming of incoming incidents and complaints into corporate CRM or ticketing systems.
- Support: Dedicated human regulatory account manager and custom enterprise SLA.
Compare plans
| Capability | Essentials | Plus | Professional | Enterprise |
|---|---|---|---|---|
| Capacity & Usage Limits | ||||
| Included Active Devices | 1 | 3 | 10 | Unlimited |
| Core Team Seats | 3* | 20* | Unlimited | Unlimited |
| External Read-Only Guest Seats | Unlimited | Unlimited | Unlimited | Unlimited |
| Included Target Markets | 2 | 5 | 8 | All Global Markets |
| Regulatory Frameworks (Gap Lists) | 3 | 10 | All Standard | All + Custom |
| Secure Document Storage | 10 GB | 50 GB | 200 GB | Unlimited |
| Cortex AI & Compute | ||||
| Included Monthly AI Credits | 1M | 5M | 10M | 100M |
| Additional Credits / Booster Packs | Pay-as-you-go | Discounted packs | Volume discount | Wholesale custom |
| Predicate Search & Gap Scoring | Starter | Advanced | Advanced | Custom Models |
| Regulatory Frameworks | ||||
| FDA QMSR 2026 (21 CFR Part 820) | ||||
| ISO 13485:2016 & ISO 14971:2019 | ||||
| EU MDR (Regulation 2017/745) | Choice of 3 | |||
| IEC 62304 (Medical Device Software) | Choice of 3 | |||
| IEC 62366-1 (Usability Engineering) | Choice of 3 | |||
| Custom Corporate Framework Builder | — | — | — | |
| Data & Security | ||||
| GDPR (Regulation 2016/679) | ||||
| ISO/IEC 27001 (Information Security) | ||||
| HIPAA (US Health Data) | ||||
| Show all frameworks | ||||
| Single Source of Truth (SSOT) | ||||
| Core Device Identity Master Record | ||||
| Multi-Market Attribute Mapping | Basic | |||
| Reactive Diff Engine (Upstream Alerts) | — | — | ||
| Cross-Device Shared Component Library | — | — | — | |
| Custom Metadata Fields & Schema Builder | — | — | — | |
| Technical Dossier Studio | ||||
| Modular Document Catalog (~45 files) | 3 Core Files | Full Catalog | Full Catalog | Full Catalog |
| Compilable Deep Generators (DDP, PRS, RTM) | 3 Basic | 14 Full | 14 Full | 14 Full |
| Pre-Structured Modular Skeletons | — | 31 Skeletons | 31 Skeletons | 31 Skeletons |
| CDMO & DMR De-duplication Logic | — | |||
| One-Click Submission Binder Export | — | — | ||
| Operational eQMS | ||||
| Document Control & Version Snapshots | Full Audit Trail | Full Audit Trail | ||
| CAPA & Non-Conformance (NCR) Modules | — | — | ||
| Customer Complaints & Post-Market Handling | — | — | ||
| Supplier Qualification (ASL) & CDMO Logs | — | — | ||
| Post-Market Surveillance (PMS / PSUR / PMSR) | — | — | ||
| Customer Feedback & Vigilance | ||||
| Embeddable Web Feedback Button | — | |||
| Harmonized Adverse Event Intake (IMDRF) | — | |||
| Native In-App SaMD Embed SDK | — | — | ||
| Automated PRRC Incident Alerting | — | — | ||
| Cross-Submission Trend Analysis | — | — | ||
| Multi-Brand Product Routing & ERP/CRM API | — | — | — | |
| Compliance, Security & Team | ||||
| 100% EU-Sovereign Cloud Hosting | Dedicated Option | |||
| Role-Based Permissions (Author/Reviewer/Approver) | Basic | Full RBAC | Full RBAC | |
| FDA 21 CFR Part 11 / Annex 11 E-Signatures | ||||
| Change-Control Locks & Audit-Freeze Modes | ||||
| External Auditor Read-Only Portal | — | — | — | |
| Enterprise REST API (PLM/ERP Sync) | — | — | — | |
| PRRC Representation Option (MDR Art. 15) | — | — | Add-on | Priority Add-on |
| Support Level | Self-Serve | Direct Email | Priority SLA | Dedicated Specialist |
* Unlimited external read-only guest roles (auditors, Notified Body assessors, external consultants) are included across all plans without consuming paid seat licenses. Guests cannot author, edit, or sign records.
Advisory & Training
Fixed-Price Expert Help
Add expert hands to any plan. Fixed scope, fixed price, no open-ended consulting hours.
QMS Kickstart
one-timeGuided setup of your ISO 13485 base: SOP tailoring, roles, and your first internal audit plan.
Design & Risk Review
one-timeExpert review of design controls, ISO 14971 risk file and usability evidence before your audit.
Launchpad Workshop
one-timeHalf-day workshop on your regulatory route, classification and market entry plan.
Fractional QA Advisor
MonthlyA senior QA reviewer on call for document approvals, questions and audit prep.
Key Benefits
Transform how your organization operates with data-driven clarity
Instant Clarity at Every Level
Eliminate status update meetings. Role-based dashboards provide the real-time KPIs needed to understand progress and make informed decisions. Identify risks faster with visual indicators that bubble up from the task level to the portfolio dashboard.
Bridge Strategy with Execution
Seamlessly translate your product vision into actionable project plans with measurable KPIs. Ensure daily work is aligned with the strategic goals that are tracked on the executive dashboard.
Maximize Your Portfolio ROI
Make confident market-entry decisions with our integrated NPV calculator. Optimize resource allocation by focusing project execution on the products with the healthiest KPIs.
From Guesswork to Governance
See how Xyreg's role-based dashboards and KPIs can provide unparalleled clarity for your product portfolio and project execution.
Setup in under 24 hours
Dedicated customer success