Regulatory & Quality
Certified quality systems. A clear path to market readiness.
Quoretech reports what has been certified, what that certification supports, and what remains before commercialization in each market.
Certification status at a glance
What Quoretech has 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.
- ISO 13485:2016 quality management certification, together with the Brazilian product, radio and health-authority records shown on this page.
- Operating proof in Brazil, where distributed cardiovascular diagnostics run at scale.
Why it matters commercially
A certified quality system is the common conformity foundation for European market entry. It means the core quality and conformity case does not have to be rebuilt market by market.
Certification is achieved. Market access is supported. Commercialization still depends on the remaining steps below, and every jurisdiction keeps its own registration decision.
What remains before commercialization
- Complete the applicable device-specific conformity and CE-marking steps.
- Draft and sign the EU Declaration of Conformity.
- Link the manufacturer registration and UDI-DI device information in EUDAMED.
- Localize the software interface, labels and instructions for use into the required national languages.
- Identify and register the applicable importer and economic operators, including packaging identification.
- Complete national registration, local representation, commercial, distribution, reimbursement, procurement, service and operating-readiness requirements.
EU MDR quality-system certification
- Certificate MDR 826817 R000
- Class IIa
- Notified Body BSI 2797
- Valid from 22 July 2026 to 21 July 2031
Quoretech’s quality management system has been assessed under Regulation EU 2017/745, Annex IX, Chapters I and III. The certificate covers cardiovascular Holter analyser devices and cardiovascular Holter analyser software, both classified as Class IIa. Continued validity is subject to BSI surveillance activities.
The legal manufacturer is Quoretech Brasil Indústria e Comércio Ltda. QTX Health, Unipessoal LDA is the European Authorised Representative.
Download certificateISO 13485 Quality Management System
Certificate MD 826814
- ISO 13485:2016
- Issued by BSI
- Valid until 6 April 2029
Quoretech’s quality management system is certified to ISO 13485:2016, the international standard for quality management systems in the medical device industry. The certification covers controlled processes supporting the design, development, manufacture, and delivery of medical devices. Continued validity is subject to periodic BSI surveillance audits.
Brazilian Product Conformity Certification
Certificate TÜV 24.0515 Rev. 00
- Product: QuoreOne
- Scope: Holter and cardiac looper, family certification
- Listed accessories: QuoreOne Docking Station D-01 and QuoreOne Charger
- Issuer: TÜV Rheinland Brasil
- Issued: 24 March 2026
- Validity: indefinite, subject to required maintenance activities and current regularity in the Inmetro database
- Certification model: Inmetro Certification Model 5, under Inmetro Ordinance 384/2020 and ANVISA RDC 549/2021
- Legal manufacturer: Quoretech Brasil Indústria e Comércio Ltda.
- Contract manufacturer: Leucotron Tecnologia da Informação Ltda.
QuoreOne and its listed accessories are certified under Inmetro Certification Model 5. The assessment includes type testing, evaluation of the manufacturer’s quality management system, factory audits, and sample testing. The certificate covers applicable ABNT NBR IEC 60601 requirements for electrical safety, electromagnetic compatibility, usability, home healthcare environments, and ambulatory electrocardiographic systems.
Download certificateBrazilian Telecommunications Conformity Certificates
TÜV Rheinland Brasil issued these product conformity certificates within the Anatel conformity assessment framework. Commercialization and use remain subject to applicable Anatel homologation.
QuoreOne Radio Conformity
- Certificate TÜV 26.0563 Rev. 00
- Product model: QuoreOne
- Product family: RF equipment excluding broadcasting
- Type: Restricted radiation transceiver
- Application: Restricted radiation radio communications
- Certification date: 14 April 2026
- Valid until: 28 November 2027
- Assessment: Type testing with periodic assessment of the product and factory management system every two years
- Applicant and manufacturer: Quoretech Brasil Indústria e Comércio Ltda.
- Manufacturing unit: Leucotron Tecnologia da Informação Ltda.
This certificate covers the QuoreOne device’s Bluetooth Low Energy radio characteristics and the applicable Brazilian telecommunications conformity requirements. The product remains subject to periodic verification that its certified characteristics are maintained.
Download certificateD-01 Docking Station Radio Conformity
- Certificate TÜV 24.0673 Rev. 01
- Product model: D-01
- Commercial name: QuoreOne Docking Station
- Product family: RF equipment excluding broadcasting
- Type: Restricted radiation transceiver
- Application: Restricted radiation radio communications
- Certification date: 25 March 2026
- Revision 01 issue date: 17 June 2026
- Valid until: 25 March 2028
- Assessment: Type testing with periodic assessment of the product and factory management system every two years
- Applicant and manufacturer: Quoretech Brasil Indústria e Comércio Ltda.
- Manufacturing unit: Leucotron Tecnologia da Informação Ltda.
This certificate covers the D-01 docking station’s Bluetooth Classic, Bluetooth Low Energy, and Wi-Fi radio characteristics under the applicable Brazilian telecommunications conformity requirements. The documentation also records the cybersecurity declaration submitted for telecommunications equipment.
Download certificateANVISA Company Authorization
- Company: QUORETECH BRASIL INDUSTRIA E COMERCIO LTDA
- CNPJ: 13.048.957/0002-30
- AFE registration: 8.28103-8 (PHYW272362X5)
- Process: 25351.743032/2023-49
- Registration date: 10 November 2023
- Status: Active
- Category: Health products (correlatos)
- Authorized activities: Store, distribute, and dispatch health products
ANVISA’s company authorization records Quoretech Brasil’s Santa Rita do Sapucaí branch as authorized for the listed activities involving health products.
It demonstrates that the branch is registered in ANVISA’s national company operating database for storage, distribution, and dispatch of health products.
QuoreOne ANVISA product registration status
- Product: QUOREONE
- Technical name: Sistema “Holter” / Holter system
- Registration number: 82424409001
- Process: 25351239793202210
- Registration holder: QUORETECH BRASIL INDUSTRIA E COMERCIO LTDA
- Holder CNPJ: 13.048.957/0001-50
- Risk classification: Class II, medium risk
- Initial validity date: 31 March 2022
- Current status: Cancelled since 26 January 2026
This record is distinct from the company authorization above: the authorization covers Quoretech Brasil as a company, while this entry is the ANVISA product record for QuoreOne.
New QuoreOne production is suspended pending completion of the regulatory regularization for the new manufacturing site.
Devices already in operation were manufactured while the registration was valid. The later cancellation does not itself invalidate those units.
In the ANVISA portal, search registration 82424409001 or process 25351239793202210.
Consult the official ANVISA record