Complete ISO 13485 System Software:

• ISOXpress can run on a single computer (Uno) or a simple network (Net) and does not require any special computer skills to install and maintain. 
• The software is easy to learn.
• The ISO 13485 documentation is simple, and there is a built-in tutorial to help you customize the documents to fit your company.
• There are instructions, tutorials and training booklets to help you understand ISO 13485 and to help you with the implementation project;
• The system is affordable to fit the budget of even the smallest company.

Mainly because small companies cannot afford to have full-time personnel dedicated exclusively to maintaining the quality system. An automated, paperless system requires much less time to maintain. With ISOXpress, just one person will be able to do the job on a part-time basis. It sounds counterintuitive, but the smaller the company, the more it will benefit from an automated, paperless system. 

To implement this system you don't have to be an expert in ISO 13485 or 21 CFR 820, but you do have to know your company and have a basic understanding of quality management systems. To assist you, the package includes:

• Employee training booklets (24 pages) to introduce you to the basic concepts of ISO 13485.
• A tutorial built into the documentation to help you customize the documents to fit your company (blue italic notes, comments, and tips);
• A tutorial built into the Internal Audit and Gap Analysis Checklist ('What to look for and how' column);
• Pictorial instructions (tutorials) to teach you how to use the software.

The only thing you need to do is to edit the documentation to fit your company. Typically you will end up retaining about 80% to 90% of the original text. You may also need to establish some work instructions.

Otherwise everything is ready to go. You will hit the ground running!

ISOXpress is so simple and intuitive to use that instructor-provided training is not necessary. There are extensive pictorial instructions (tutorial slides) in the software itself.

Yes, you can call us at 800 600 3601 or 626 796 9000 any work day between 9 am and 5 pm Pacific, or send an email to support@isoxp.com.

• Windows 2000 or higher
• Memory 250 MB or higher
• Adobe Reader (free PDF Reader)