Quality and compliance — auditable, verifiable, no asterisks.
The certifications below are the operational base of Loumey Medical. Each is accompanied by its registration number and downloadable certificate for independent verification. If your tender requires additional certifications, we can demonstrate documented compliance.
- MSP Uruguay
Importer authorization
Entity authorized by the Uruguayan Ministry of Public Health as importer, distributor and technical-service provider for medical devices.
- ANMAT · Argentina
Registration capability
Documentation and procedures aligned with the Argentine National Administration of Drugs, Foods and Medical Devices for product registration.
- ANVISA · Brazil
Registration capability
Procedures compatible with the Brazilian Health Regulatory Agency for medical device registration in the Brazilian market.
- INVIMA · Colombia
Registration capability
Documentation aligned with the requirements of the Colombian National Institute of Drug and Food Surveillance.
- CE / MDR 2017/745
European marking
Capacity to manage and document equipment with CE marking under the European Medical Device Regulation.
- IEC 60601-1
Electrical safety
Verifiable compliance with the basic safety standard family for electromedical equipment.
Anti-corruption policy and Integrity Pact
Loumey Medical signs an Integrity Pact in every public tender it participates in. Our internal policy categorically prohibits any form of facilitation payment, informal commission or gift to public or private officials with decision-making power over our commercial proposals. The policy is audited annually and findings are publicly documented in our governance report.
Confidential whistleblower contact: office@loumey-medical.com. Reports are processed by an independent external committee.
Does your tender require specific QMS documentation?
We can prepare the complete documentation package (GMP, signed technical sheet, manufacturer warranties, as-built drawings, certificates of origin) in less than 5 business days.