Devine Guidance International, Inc.

medical devices

About

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.

Technologies

Outlook Amazon AWS Google Maps AI

Keywords

compliance quality management consulting services regulatory affairs internal audits supplier audits medical equipment manufacturing eu mdr support validation review post-market surveillance fda form 483 response medical devices mdsap eu 2017/745 mdr warning letter remediation clinical evaluation reports consulting other scientific and technical consulting services device industry compliance quality management system audit facilitation b2b manufacturing 510(k) submissions medical device compliance supplier management systems iso 9001:2015 iso 13485 healthcare services qa & ra consulting

Location

4730 S Fort Apache Rd, Las Vegas, Nevada, United States, 89147

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