Software ISO for 13485:2003 ISO 14971:2000 management system

ISO 13485:2003/14971:2007 software to develop Quality & Risk Management System for medical devices

If you are looking for a reliable, easy-to-use, affordable and efficient software that should help your company in developing, implementing and maintaining the Quality Management System for medical devices (ISO 13485:2003, ISO 14971:2007 Standards), lean back and relax - you have just found it! ISO-MED is the software!

"ISO-MED" program (software for ISO 14971/ISO 13485 certification) consists of the following modules:

"Documents" (control of documents and records of the management system).
This software module will help you to develop effective management/control system for Quality and Risk Management system documents and records, thus fulfilling requirements of Ch. 4.2 ISO 13485:2003. In fact, the module "Documents" itself presents a dedicate affordable software that (together with "Correspondence" module) will help you to establish effective document and record control & management system for your organization's management system.
"Risks" (Risk Management File).
This program module is, basically, the Risk Management File in terms of Ch. 3.6 of ISO 14971:2007. It will assist you to set up the Risk Management System - i. e., to identify hazards in your business system, assess associated risks and determine measures to control the risks, to conduct the risk/benefit analysis and determine acceptability of the risks identified for your business in full correspondence with the procedure determined in ISO 14971:2007 Standard.
"Processes" (description/management of business processes, "process approach").
This software module is intended to realize requirements of Ch. 0.2 "Process approach", Ch. 5.2 "Customer Focus", Ch. 7.2 "Control customer processes", Ch. 8.2.3 "Monitor and measure quality processes" of ISO 13485:2003.
"Trainings" (competency, qualification and training of personnel).
This module will help you to develop a system of evaluation of competencies required for personnel involved in the Management System activities, plan and control the training system for the personnel per requirements of Ch. 6.2. "Provide quality personnel" of ISO 13485:2003.
"Audits" (audits/corrective actions/preventive actions).
This module will help you to establish the effective system for internal audits/corrective actions/preventive actions as per requirements of ch. 8.2.2 "Audits", Ch. 8.5.2. "Corrective actions", Ch. 8.5.3 "Preventive actions".
"Equipment" (equipment management).
This module will assist you to set up the system for control of your organization's equipment (incl. the equipment intended for quality management needs), thus meeting the requirements of Ch.6.3 and Ch. 7.6 of ISO 13485:2003 Standard. .
"Complaints" (dealing with customer complaints). This module is to help in developing the system for monitoring of and effective dealing with customers complaints (Ch. 7.2.3, Ch. 8.2 of ISO 13485:2003).
"Non-conformities".
Registration/control of non-conformities, comparative analysis of non-conformities, quantitative evaluation of effectiveness of Management System, graphical representation of the results of analysis (Ch. 8.3, Ch. 8.4 ISO 13485).
"Correspondence" (control of "non-system" documents).
This module will help you to effectively control a flow of "non-system" documents of your organization (letters, orders, etc.)

Along with the modules mentioned above, ISO-MED features advanced capabilities, such as:

WEB-interface - intranet or Internet access for users working on remote PCs;
a tool for internal communications in "real-time" mode;
built-in editors of process diagrams (flow-charts);
tools for quantitative evaluation of effectiveness of the Management System;
tools to keep customer and supplier registers, etc., etc.
multilingual interface. Below you can see languages which ISO-MED speaks:

(if your language is missing in the list please let us know about it and we will incorporate the language in the software interface).

Even the most demanding users will be pleasantly surprised by the ISO-MED.

Is it interesting to you? We hope - yes. So now you can:

Download the software installer
Take a closer look at description of various modules of the software.
Get to know with the software price list.
Join our Partner Program - it will enable you to buy the software with a huge discount and earn money with us!

So, welcome to "ISO-MED" software site - you could hardly find another program that will help your company to build Qulaity and Risk Management System for medical devices in accordance with requirements of ISO 13485:2003 and ISO 14971:2007 standards!