The resolution RDC 59 approved on June 27, 2000 is a set of mandatory requirements imposed by ANVISA for manufacturers and distributors of medical and dental products. Meeting RDC 59 requirements also known as (GMP) Good Manufacturing Practice or (GDP) Good Distribution Practice is compulsory.

RDC 59 is based on the requirements imposed by FDA in the United States of America (USA) where it is known as Good Manufacturing Practices (GMP). Therefore we can better define GMP as a Quality Management System specially created for manufacturers and distributors of medical and dental equipments. Read more on GMP/RDC59.

Why is K.mind unique when it comes to GMP/GDP/RDC59?

K.mind is not only aimed at meeting regulations, but also at building a Management System, better still, an Organizational Model that aims to fulfill regulations without constraining growth, profitability and sustainability. Along with services, we also provide clients with software designed to increase productivity and implement an intranet to documentation management and access. Our software is a synonym of efficacy in implementation and expense reduction on printed documents.

The implementation of RDC 59/GMP/GDP is integrated with other quality regulations such as: ISO 9001, ISO 14001 or ISO 13485, making process optimization among other activities related to the subject possible. In addition to it, K.mind works in partnership with clients to produce quality documents.

K.mind achievements are the direct results of its technical team formed by highly specialized people who have Master and Doctorate in Management, Medicine and Biomedicine Engineering.

How can we serve you?

K.mind has different ways of providing clients with services so that we can fulfill each client's particular need through personalized and strategy-aligned projects. When it comes to RDC59/GMP/GDP the K.mind offers training as well as outsourcing of the quality management process.

To know more about the way we provide RDC59/GMP/GDP click here: