Question 1

What is Xyreg?

Accepted Answer

Xyreg is a unified workspace for medical device teams. It combines eQMS, product lifecycle management, the regulatory dossier and financial tracking in one audit-ready environment, so technical development and compliance stay connected instead of living in separate silos.

Question 2

What is actually inside the workspace?

Accepted Answer

An ISO 13485 QMS with auto-generated SOPs, ISO 14971 risk management, IEC 62366 usability engineering, design control and V&V, an audit-ready Design History File, plus operational quality on the Helix Workspace plan: CAPA, complaints, supplier and document control, post-market surveillance, PMCF and vigilance.

Question 3

How fast can we be ISO 13485-ready?

Accepted Answer

Days, not months. Xyreg generates your SOP and QMS baseline automatically and connects it to live traceability from user needs to risk to usability to verification and validation, so the documentation is built as you work rather than reconstructed before an audit.

Question 4

Is Xyreg suitable for my company size?

Accepted Answer

Genesis is for pre-revenue teams of up to 2 core seats building their first device. Helix Workspace is for funded and scaling teams running full operations and post-market activity. PRRC as a Service sits on top for manufacturers who need the regulatory role covered without hiring.

Question 5

Do you offer integrations or a public API?

Accepted Answer

Not yet. Xyreg is a self-contained workspace today, and a documented API plus third-party connectors are on the roadmap. In the meantime you can import and export your data, and if you have a specific integration need, raise it on a demo call so we can plan it with you.

Question 6

Is there a free tier?

Accepted Answer

No. There is no free tier and no free-forever program. Every plan starts with a 7-day free trial. A credit card is required to start, and you can cancel any time during the trial at no cost.

Question 7

What happens when the trial ends?

Accepted Answer

If you do nothing, the trial converts to the plan you selected and billing starts. Cancel before day seven and you are not charged.

Question 8

Do I keep my data if I subscribe after the trial?

Accepted Answer

Yes. Everything you build during the trial, your QMS baseline, SOPs, risk files and traceability, stays in your workspace when you subscribe.

Question 9

How does pricing work?

Accepted Answer

Pricing is plan-based, tied to your stage rather than billed per seat. Each plan comes with a defined user tier, so you are not paying an extra licence every time someone joins a project.

Question 10

What does each plan cost?

Accepted Answer

Genesis is €290/month on the annual plan (€349/month month-to-month) with a maximum of 2 core seats. Helix Workspace is €990/month on the annual plan (€1,190/month month-to-month) with all modules included. PRRC as a Service starts at €2,990/month for Class I devices and includes the full Helix Workspace. Investor packages are available for VCs, angels and incubators.

Question 11

What is the difference between annual and monthly billing?

Accepted Answer

On the annual plan you pay for 10 months instead of 12, so two months are effectively free. Month-to-month billing is available at the higher rate with no long-term commitment.

Question 12

Who qualifies for Genesis?

Accepted Answer

Genesis is strictly for pre-revenue teams: pre-seed or grant funded, under €250k raised, no launched product, and a maximum of 2 core seats. Once you raise beyond that, launch a device or grow the team, you move to Helix Workspace.

Question 13

Can I add modules to Genesis?

Accepted Answer

Yes. Genesis is intentionally focused, and specialist modules can be added for €50/month each if you need capability beyond the core build scope.

Question 14

Can I change plans as we grow?

Accepted Answer

Yes. The upgrade path from Genesis to Helix Workspace is designed to be seamless, and all of your data, documents and traceability carry over untouched.

Question 15

What is QMSR and why does it matter?

Accepted Answer

QMSR (Quality Management System Regulation) is the FDA's harmonised approach aligning with ISO 13485. Xyreg is QMSR-native, meaning the workspace architecture inherently supports the process-based, risk-thinking requirements of modern quality management.

Question 16

How does Xyreg help with regulatory submissions?

Accepted Answer

Xyreg generates submission-ready documentation directly from your engineering data, including FDA 510(k) technical files and EU MDR dossiers, with the correct document hierarchy and traceability already in place.

Question 17

How is the software validated when you release updates?

Accepted Answer

Validation follows an AAMI TIR80002-2 aligned, risk-based approach. Each release ships with revalidation evidence generated for you, so you keep a documented validated state without running a manual validation project every time we update the workspace.

Question 18

What is PRRC as a Service?

Accepted Answer

Under Article 15 of the EU MDR you need a qualified Person Responsible for Regulatory Compliance. With PRRC as a Service, Xyreg holds that role and does the hands-on work, keeping the technical documentation current and handling vigilance and post-market obligations. It starts at €2,990/month for Class I devices and includes the full Helix Workspace.

Question 19

Where is my data hosted?

Accepted Answer

In the EU, on sovereign OVHcloud infrastructure. Your intellectual property and regulatory records stay under European jurisdiction.

Question 20

How is my data protected?

Accepted Answer

Xyreg runs on ISO 27001 aligned infrastructure with encryption in transit and at rest, role-based access control and a full audit trail on every record.

Question 21

Does Xyreg Cortex AI train on my data?

Accepted Answer

No. Cortex AI processes your content in isolated environments and never trains models on your proprietary information. Your data is never shared with other customers or used to improve public models.

Frequently Asked Questions

Product & Features

Trial & Getting Started

Pricing & Plans

Compliance & Regulatory

Security & Data Sovereignty

Still have questions?