Implementing Medical Device Standards into a Quality Management System

by Michael B. Checketts published on September 22, 2022

Start-up Medical Device companies consistently develop devices which they expect will greatly improve patient Quality of Life. Generally, through consultant regulatory help it is fairly easy to get the regulatory filings done which include device classification. However, when it comes to the Quality Management System (QMS), it seldom matches the organization’s real management system processes. Too often they are initially over complex, or substantially lacking. Of course, the QMS must meet FDA and international standards, and now that FDA is in-process of integrating ISO 13485 into 21 CFR 820 requirements, where do you go from here?

It’s best to start with a Quality Manual (QM), so here are a few simple steps on how to start.

The services of OMNEX would be invaluable in any of the above scenarios, or in most any situation your company might find itself. Every organization is different, and no one plan will work for all. Let Omnex help guide you through the QMS/Regulatory maze with a system that works for the future of your organization.

Read this white paper to learn how Medical Devices standards can be implemented into a Quality Management System.