Combination Kit for ISO 13485


Combination kit for ISO 13485 medical devices manufacturer that needs to get the ball rolling from paper-based management to paperless QMS.


Part 1 of 2 Combination kit for ISO 13485: MS Office documents to enable your Company to operate a paper-based management system while it transitions to a paperless QMS. (25MB download)

Bare Minimum MS Office ISO 13485 Document List

Part 2 of 2 Combination kit for ISO 13485: Complete Efficient QMS™ to enable your Company to achieve paperless management while operating its paper-based management system.

Efficient QMS(tm) ISO 13485 Document List

Click/tap here to learn more about paperless Efficient QMS™.

Tech-support for Efficient QMS™ is no charge and has no expiration. Tech-support for your Company’s quality improvement program is no charge by phone and email and also has no expiration. That means you can call anytime during your Office hours to ask burning questions, such as, “I’ve got to do what!”.

We recommend web hosting for eQMS at Hostgator because (by default) their lowest cost plan provides a Linux/Nginx webhost operating system and required software: PHP 7.4, Zend Engine, ionCube Loaders and MySQLi.

We’ll install eQMS for you at no charge when you provide access to your cPanel (web address, username, password). During our installation, we’ll replace the temporary eQMS license with a permanent license. When you install the paperless management system, email us your domain name or private webhost IP address and we’ll send you the perm-license.

Efficient QMS™ requires no User fees, hosting or leasing fees, annual support fees or subscription fees, and is as easy to install as WordPress – isn’t that refreshing! In addition, your Company backs-up and manages the database and Hostgator regularly backs-up all files in your domain.