Certifications

Our concept of quality is based on customer satisfaction and a philosophy of continuous improvement. We seek to provide the best electrosurgical solutions for healthcare professionals and patients.

Our products are designed, developed and manufactured under strict national and international safety standards. All of our products count on the legal registrations required by the authorities.

Likewise, our manufacture processes and facilities comply with the Good Manufacturing Practices regulations as required by The National Administration of Drugs, Foods and Medical Devices (ANMAT) and the Argentine Ministry of Health in accordance with current legislation.

Our facilities at Minicomp count on ideal sanitary spaces for the manufacturing of medical products. There is a clean area for the manufacturing of sterile products and we count with the ultimate measuring instruments and the latest engineering technology.

Certifications

BPF (ANMAT – The National Administration of Drugs, Food and Medical Devices)

We work in compliance with Good Manufacturing Practices (GMP) regulations as per current legislation. Our plant complies with the standards required by the health authorities and has been granted the Certificate of Registration and Business Operation by ANMAT. (Disp 5550/2017)

ANMAT PM-1463-X REGISTRATION

Our products comply with the regulations and standards required by the health authorities and count with their certificates of registration as medical products. (Disp 0418/2018).

IRAM 4220 / IEC 60601-1 / IEC 60601-2-2 Registration

Our product complies with the General and Particular Electrical Safety standards and the Electromagnetic Compatibility standards.

DOUBTS, QUESTIONS?

Contact us now, we will give you answers