eIFU security and hosting in the EU
DocuLiv is developed and operated by Cognito Works under an information security management system certified to ISO/IEC 27001. Data is hosted in a Prague data centre. Request documentation on hosting, certifications and operational controls for your supplier assessment.
Cognito Works · ISO/IEC 27001
DocuLiv is developed and operated by Cognito Works, a member of the Cognito group, with an information security management system certified to ISO/IEC 27001.
vshosting, Prague · ISO/IEC 27001:2022 and ISO/IEC 27017:2021
Data is hosted in the EU, in the Prague data centre of vshosting, part of the German Contabo Group (Munich) with data centres in Prague, Düsseldorf and other locations, certified for information security and for cloud service security.
How we protect your IFUs
How DocuLiv helps you meet the eIFU requirements
| Requirement | How DocuLiv supports it |
|---|---|
| Website protected and available | EU hosting with ISO/IEC 27001 and 27017, firewall, 24/7 monitoring, 99.9 % availability. |
| Previous versions retrievable | Versions per batch, superseded versions kept with their dates, complete change log. |
| Free paper copy on request | Users request a paper copy in the portal. The manufacturer is responsible for delivering it within the required time, at the latest within 7 calendar days. |
| Languages of the markets | 24+ languages, each language version per market, batch and REF. |
| Easy access for professional users | QR code, REF, UDI or product name; protected areas for healthcare professionals. |
| Integrity of documents | Digital signatures and timestamps (Enterprise), audit trail in every plan. |
Compliance with the regulation is demonstrated by the device manufacturer. DocuLiv provides the technical means and supporting documentation, including validation documentation templates for your QMS. For in vitro diagnostics, electronic instructions are governed by the IVDR (Annex I, Section 20.1(f)): they are allowed for devices intended for professional use only, except devices for near-patient testing.
Frequently asked questions
Where is DocuLiv hosted?
In the EU, in the Prague data centre of vshosting, part of the German Contabo Group, certified to ISO/IEC 27001:2022 and ISO/IEC 27017:2021.
Who develops and operates DocuLiv?
Cognito Works, s.r.o., a member of the Cognito group, with an information security management system certified to ISO/IEC 27001. The contracting party is Cognito.CZ, s.r.o.
Does DocuLiv guarantee compliance with MDR or IVDR?
No software can: compliance is demonstrated by the device manufacturer. DocuLiv provides the technical means to support Regulation (EU) 2021/2226 and validation documentation templates.
Is personal data transferred outside the EU?
No. Data stays in the EU; e-mails from the website forms are delivered via Brevo in France.
Need details for your supplier assessment?
We answer your security questions and walk your QA team through the platform.