Devine Guidance International, INC.

Dr. D's Books on Quality & Regulatory Affairs are available at amazon.com

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

Dr. Devine's Medical Device Summit Interview

Discussion on quality assurance and regulatory affairs.

Med-Tech Intelligence

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

In The News

operationalizing compliance strategies from bench to bedside

DGII delivers end-to-end compliance solutions through consultants who bring both regulatory authority and the technical expertise required to implement, sustain, and defend compliant systems.

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.

customized qa & ra consulting