Quality and Regulatory Dollars are at a premium, why not outsource some of your QA and RA Support needs to qualified consultants?


Let's be realistic here. Quality and regulatory requirements are continuing to evolve and grow more complex every day. Complexity and change equates to additional organizational expense. The cost of business travel and lost employee hours associated with travel to supplier facilities for audits is also a significant expense. DGII can reduce the costs associated with quality and regulatory support by providing services needed to support your organization's day-to-day quality and regulatory activities mandated by regulations and standards. 



Devine Guidance International

Link to Dr. D's best-selling book; "Devine Guidance for Complying with 21 CFR, Part 820 (FDA's Quality System Regulation)

Med-Tech Intelligence

A link to Dr. Devine's weekly blog on quality and regulatory issues.

In The News

Med-Tech Intelligence

A link to Dr. Devine's weekly blog on quality and regulatory issues.



Dr. D's New Book has just been released!

​Devine Guidance - A Compilation of Dr. D's Quality & Regulatory Articles from 2014. 

We Provide Solutions!

Navigating the often treacherous waters of quality and regulatory requirements associated with the medical device industry requires a unique set of skills and expertise. At Devine Guidance International we can help provide the quality and regulatory expertise needed to remain in compliance with US FDA regulations and applicable regulations outside of the United States. 



Dr. Devine's Medical Device Summit Interview - January 2012

​Discussion on quality assurance and regulatory affairs. 

Providing QA & RA Support