Would you like a worry- free future?


If you are in the device industry it is not a question of if the FDA will visit your facility for an inspection, it is a question of when will the FDA visit your facility? Is your organization prepared? 

The most important thing is safe & effective devices

Devine Guidance International, Inc. (DGII) was founded in March of 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, DGII provides solutions for resolving Quality Management Systems, Quality Control, and Regulatory Compliance issues.




Dr. Christopher J. Devine, the founder of DGII, 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.

Experience

About Us

DGII is dedicated to ensuring our clients quality and regulatory compliance goals are achieved.

What Really Matters

Devine Guidance International

Devine Guidance for Complying with 21 CFR, Part 820 - The FDA's QSR

Devine Guidance for Managing Key Attributes of a FDA-Compliant Quality Management System


Devine Guidance for Complying with 93/42/EEC - The EU's MDD 


Relevant Reading


Available through Amazon.com

 "There is no such thing as maximum compliance or minimum compliance in the medical device industry,there is only compliance!" - Dr. C. J. Devine -

 

  • DGII can assist with the performing of internal audits and supplier audits in accordance with ISO 9001:2015; ISO 13485:2016; 93/42/EEC; (EU) 2017/745 (MDR); SOR/98-282; ISO 14971:2019; ISO/IEC 17025:2017; MDSAP and 21 CFR, Part 820 Requirements (including Parts 801, 803, 806 & 820).


  • DGII can assist with FDA warning letter remediation activities.


  • DGII can provide short-term on-site support in a variety of QA & RA Functions.


  • DGII can facilitate your notified body audits & FDA inspections.


  • DGII can author your 510(k) and Technical File submissions.


  • DGII can author your Literature Search Reports and Clinical Evaluation Reports in accordance with (EU) 2017/745 (MDR) requirements.


  • DGII can write procedures for your Quality Management System (QMS) or script your entire QMS.


  • DGII can script you Post-Market Clinical Follow-up Reports and Clinical Evaluation Reports in accordance with (EU) 2017/745 (MDR) requirements.