Devine Guidance International, Inc. is a firm specializing in providing Quality Management System and Regulatory Compliance consulting services for the medical device industry. Our areas of expertise are rooted in the development and implementation of Quality Management Systems (EN ISO 13485:2012, ISO 9001:2008, & 21 CFR, Part 820) , Internal Audits, Supplier Audits, Validation Reviews (IQ, OQ, PQ & PPQ), FDA Form 483 & Warning Letter Mitigation, and the Review of Regulatory Submissions; 510(k)s and Technical Files.