Devine Guidance International, INC.
Devine Guidance International, Inc. (DGII) was founded in March 2011 by Dr. Christopher J. Devine, with the vision of creating a consulting firm that provides substantial value for medical device manufacturers by offering real solutions for day-to-day issues facing the industry. As the device industry grows increasingly complex, DGII provides solutions for resolving Quality Management Systems, Quality Control, and Regulatory Compliance issues.
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Dr. Cynthia N. Brysch is the Vice President and Chief Operating Officer of DGII. She is a globally recognized Quality Assurance and Regulatory Affairs executive and published biotechnologist with over 20 years of leadership across pharmaceuticals, biotechnology, medical devices, and combination products.
Dr. Brysch partners with executive teams and boards to build, remediate, and scale inspection-ready Quality Management Systems (QMS) aligned with FDA and global requirements, including 21 CFR Parts 210/211, 820 (QMSR), ISO 13485, MDSAP, EU MDR/IVDR, and ICH guidelines. She has overseen more than 500 programs across both startup and established organizations, with direct experience supporting NDA, BLA, PMA, 510(k), and IDE pathways and deep expertise in ICH clinical frameworks. She serves as an FDA Advisor, ICH committee member, ISO accrediting authority, and CAP/CLIA inspector.
She holds a PhD in Health Sciences from Liberty University and brings deep scientific and regulatory expertise spanning the full product lifecycle—from early development through commercialization.
Relevant Reading
"There is no such thing as maximum compliance or minimum compliance in the medical device industry,there is only compliance!"
- Dr. C. J. Devine
Turn Risk Into Readiness, Starting Now
If you are in the life science industry, it is not a question of IF the FDA will visit your facility for an inspection, it is a question of WHEN they will visit. Is your organization prepared?
DGII is dedicated to ensuring our clients' quality and regulatory compliance goals are achieved.
Leadership
Dr. Christopher J. Devine is the founder of DGII. He has over 40 years of combined experience in the fields of quality assurance and regulatory affairs; and is a senior member of the American Society of Quality (ASQ), a member of Regulatory Affairs Professionals Society (RAPS), a member of the Society of Manufacturing Engineers (SME), and a member of the Project Management Institute (PMI).
Dr. Devine received his doctorate from Northcentral University, with his doctoral dissertation entitled, “Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: A Mixed-Method Study. Prior to launching his commercial career, Dr. Devine served honorably in the United States Marine Corps.
Devine Guidance for Complying with 21 CFR, Part 820 - The FDA's QSR
Devine Guidance for Complying with 93/42/EEC - The EU's MDD
Devine Guidance for Managing Key Attributes of a FDA-Compliant Quality Management System
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What Matters Most? Customized Compliance Solutions
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