TYSMED — Equipos Médicos

Certifications

Audit-ready paperwork, every time.

Every TYSMED shipment includes complete regulatory documentation — at no extra cost. Here's what each certification actually guarantees for your facility.

FDA
CE
ISO 13485
ISO 9001
ISO 14971
IEC 60601
COFEPRIS
ANMAT
DIGEMAPS
DGA
FDA
U.S. Food and Drug Administration

510(k) clearance and registration for medical devices marketed in the United States. The world's most demanding device regulator.

What it guarantees: The device has been reviewed for safety and effectiveness equivalent to a legally marketed predicate.
CE
European Conformity (MDR 2017/745)

Mark required to sell medical devices in the European Union and EEA, issued by a Notified Body.

What it guarantees: Compliance with EU safety, health and environmental protection requirements.
ISO 13485
Medical Device Quality Management Systems

The international quality standard specific to medical device manufacturers.

What it guarantees: Manufacturer maintains documented design, production and post-market controls.
ISO 9001
Quality Management Systems

General quality management standard applicable to manufacturers and distributors.

What it guarantees: Consistent processes for product quality and customer satisfaction.
ISO 14971
Risk Management for Medical Devices

International standard for the application of risk management to medical devices.

What it guarantees: Hazards identified and mitigated across the device lifecycle.
IEC 60601
Medical Electrical Equipment Safety

Family of standards covering basic safety and essential performance of medical electrical equipment.

What it guarantees: Electrical, mechanical and EMC safety for patient-connected devices.
COFEPRIS
Mexico — Federal Commission for Protection against Sanitary Risk

Regulatory registration recognized across Latin America.

What it guarantees: Sanitary registration valid in Mexico and used as reference across LATAM.
ANMAT
Argentina — National Drug & Medical Device Administration

Argentine regulator recognized by Mercosur countries.

What it guarantees: Registration in one of the strictest Latin American markets.
DIGEMAPS
DR Ministry of Public Health (MISPAS)

Local registration for the import and commercialization of medical devices in the Dominican Republic.

What it guarantees: Legal authorization to sell and install devices in DR healthcare facilities.
DGA
Dirección General de Aduanas

Customs clearance with proper tariff codes and ITBIS reporting.

What it guarantees: Legal importation with full traceability.

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