FEDER_ENG

WIEMSPRO SL in the ICEX Next Program, has had the support of ICEX and the co-financing of the European ERDF fund. The purpose of this support is to contribute to the international development of the company and its environment.

Certifications

The Wiemspro Electrostimulation System has the most demanding product, health and technology Certifications Worldwide.

Certificado Wiemspro por la FDA

The Food and Drug Administration is responsible for ensuring that food, drugs, and certain other products and processes are safe for consumers from USA.

Certificado Wiemspro por ANVISA

The Brazilian Health Regulatory Agency is an autarchy linked to the Ministry of Health, part of the Brazilian National Health System as the coordinator of the Brazilian Health Regulatory System.

Certificado Wiemspro por la INVIMA

The Colombia National Food and Drug Surveillance Institute is in charge of inspecting and supervising the marketing and manufacturing of health products, and providing medical approval for the import and export of products.

Certificado Wiemspro por la CE

The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements.

Other Certifications

IEC 60601-1-2: 2007

Electromagnetic compatibility.

IEC 62304

Medical Device Software.

IEC 60601-2-10: 2012

Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.

IEC 60601-1-6 Edition 3.1 2013-10

General Requirements for Basic Safety and Essential Performance – Collateral Standard: Usability.

ISO 14971 Second Edition 2007-03-01

Application of risk management to medical devices.

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