Scale and global reach
A regulatory foundation for disciplined international expansion.
Quoretech combines operating proof in Brazil with an EU MDR-certified quality system covering its Class IIa cardiovascular Holter analyser device and software. This creates a common foundation for European entry and can support reliance-based pathways in selected markets.
Markets
- 1
Brazil — Operating
Established diagnostic operations and the company's largest evidence base.
- 2
Portugal — Market entry in progress
European operating foundation and market preparation.
- 3
France — Launch preparation
Regulatory and commercial preparation.
Achieved
- EU MDR quality-system certificate
- MDR 826817 R000, issued by BSI, notified body 2797, covering the Class IIa cardiovascular Holter analyser device and software, valid through 21 July 2031.
- ISO 13485 quality management
- Certified quality management system for medical devices.
- Operating proof in Brazil
- Distributed cardiovascular diagnostics running at scale.
European opportunity
Once the applicable product-specific CE-marking and market-entry obligations are complete, the EU MDR framework can support commercialization across 30 European markets: the 27 EU Member States plus Iceland, Liechtenstein and Norway, under a shared rule set.
That common foundation may reduce duplicated conformity work, rather than rebuilding the core product conformity case country by country.
Before commercialization
- EU Declaration of Conformity
- Drafted and signed for the applicable devices.
- Product-specific CE marking
- Remaining device-specific conformity steps completed.
- EUDAMED registration
- Manufacturer registration and UDI-DI device information linked.
- Translations
- Software interface, labels and instructions for use in the required national languages.
- Importer and economic operators
- Identified and registered, including packaging identification.
- Local operating readiness
- National registration, representation, distribution, reimbursement, procurement and service.
Further regulatory leverage
Examples of where European evidence may support a route to market. Every jurisdiction retains its own approval or registration decision.
Great Britain
Qualifying EU MDR CE-marked devices are accepted through 30 June 2030, with a UK Responsible Person and MHRA registration required.
Northern Ireland
Follows the EU MDR framework, with its applicable registration and economic-operator requirements.
Switzerland
Recognizes EU conformity evidence, and requires a Swiss authorised representative and national registration.
Australia
EU evidence may support an abridged or comparable-evidence pathway, subject to classification, dossier and TGA review.
Singapore
EU evidence may support a reliance or abridged evaluation route, subject to eligibility, local representation and authority review.
Malaysia
EU evidence may support a verification-based registration route, subject to classification, representation and authority review.