Design of a validation protocol for medical technology according to current standards

Abstract

Currently, every company of designs and manufactures medical devices should have a solid quality assurance system focused on product and service quality with minimal manufacturing errors, meeting the specifications proposed by the company and the norms of the country, looking to benefit patients and health authorities. This article presents a methodology for designing validation protocols for medical technology; starting with a review of national and international standards and processes, continuing with the protocol design for tests according to a particular device and finally analyzing the results and making necessary adjustments to improve the quality of patients life through safe technologies, looking to improve services in different hospital environments, making sure that a device works properly and introduce to the market in accordance with the stipulated standards and specification.