Devine Guidance International, Inc. is a consulting firm specializing in providing industry support for regulatory affairs, quality compliance, clinical studies, quality system design and implementation, procedure writing, supplier management, supplier audits, internal audits, supply-chain management, and FDA warning letter mitigation activities for the medical device industry. Devine Guidance International, Inc. is headquartered in Las Vegas, Nevada.Published Author: Devine Guidance for Complying with the FDA's Quality System Regulation "21 CFR, Part 820;" Devine Guidance for Complying with the European Medical Device Directive (MDD) "93/42/EEC;" and Devine Guidance for Complying with the European In Vitro Diagnostics Directive (IVDD) "98/79/EC;" Devine Guidance for Complying with Ministerial Ordinance 169 (Japan's Quality System Regulation) - books available through amazon.com or http://devineguidanceinternational.com.Specialties: Dr. Devine is well-versed in activities relating to quality, regulatory, clinical, operations management, program management, and possess a PhD, supported by a doctoral dissertation entitled; "Exploring the Effectiveness of Defensive-Receiving Inspection for Medical Device Manufacturers: a Mixed-Method Study." Devine's regulatory expertise is based on compliance with the following regulations and standrds: (a) 21 CFR, Parts 801, 803, 806, 807, 810, 812, 814, & 830; (b) (EU) 2017/745 (MDR); (c) (EU) 2017/746 (IVDR); (d) MDSAP; (e) ISO 9001; (f) AS 9100; (g) ISO 13485; (h) ISO 14971; (i) SOR/98-282 (Canada); (j) Ministerial Ordinance 169 (Japan); (k)Therapeutic Goods Regulation 2002, Schedule 3 (Australia); and (l) Brazil ANVISA Resolution RDC 16:2013.
Listed skills include Iso 13485, Medical Devices, Regulatory Submissions, Quality System, and 45 others.
