Devine Guidance International was founded in 2011 by Dr. Christopher J. Devine, with the vision of creating a consulting firm that provides substantial value for medical device manufacturers by providing real solutions for day-to-day issues facing the industry. As the device industry grows increasingly complex, our consultants provide support for resolving compliance, quality, regulatory, supplier, and supply-chain management issues. Additionally, DGII provides internal auditing and supplier auditing services to ISO 9001:2008; EN ISO 13485:2012; and 21 CFR, Parts 803, 806, 807, 820 and 1271. Furthermore, DGII can assist in the implementation of your organization's Quality Management System; and provide support during notified body audits and FDA inspections. Finally, DGII provides support needed for generating 510(k)s and Technical Files.