Skip the Hire
From €2,990/month (Class I). Xyreg acts as your Person Responsible for Regulatory Compliance under Article 15 MDR, doing the hands-on work and carrying the accountability. Full Helix Workspace included.
From €2,990/month for Class I devices · Helix Workspace included
The Problem
MDR Article 15 requires a qualified PRRC. Hiring one costs a senior salary you cannot justify yet, and a part-time consultant who only advises still leaves the work and the risk on your desk.
The Solution
Xyreg takes the PRRC role and does the work: we run and sign off the regulatory outputs, keep the technical documentation current, handle vigilance and post-market obligations, and answer to your notified body. Full Helix Workspace is included, so software and the role come as one. Starts at €2,990/month for Class I devices.
What you get
A named, qualified PRRC who does the work and carries the accountability.
* €2,990/month applies to Class I devices. Contact us for a quote on Class IIa, IIb and III.
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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.
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.