Devine Guidance International
Consulting firm providing quality assurance and regulatory affairs support to medical device manufacturers, including QMS design and documentation, auditing, regulatory submission authoring, post-market clinical evaluation, validation review, and remediation for FDA and notified body findings.
Industries
Nr. of Employees
small (1-50)
Devine Guidance International
P. O. Box 1486, Yerington, NV 89447
Products
Devine Guidance for Complying with 21 CFR, Part 820 (FDA QSR)
Book providing guidance on complying with 21 CFR Part 820 quality system regulation for medical devices.
Devine Guidance for Complying with 93/42/EEC (EU MDD)
Book providing guidance on complying with EU medical device directives and related technical file requirements.
Devine Guidance for Complying with 21 CFR, Part 820 (FDA QSR)
Book providing guidance on complying with 21 CFR Part 820 quality system regulation for medical devices.
Devine Guidance for Complying with 93/42/EEC (EU MDD)
Book providing guidance on complying with EU medical device directives and related technical file requirements.
Services
Assessments of existing QMS to identify gaps and remediation actions.
Design and scripting of QMS procedures and quality manuals to meet regulatory standards.
Execution of internal and supplier audits in accordance with ISO and regulatory standards.
Authoring of 510(k) submissions for US FDA and Technical Files for EU device classifications.
Authoring Clinical Evaluation Reports and Post-Market Clinical Follow-up reports to support EU MDR compliance.
Support for corrective and preventive actions and complaint handling processes.
Assessments of existing QMS to identify gaps and remediation actions.
Design and scripting of QMS procedures and quality manuals to meet regulatory standards.
Execution of internal and supplier audits in accordance with ISO and regulatory standards.
Authoring of 510(k) submissions for US FDA and Technical Files for EU device classifications.
Authoring Clinical Evaluation Reports and Post-Market Clinical Follow-up reports to support EU MDR compliance.
Support for corrective and preventive actions and complaint handling processes.
Expertise Areas
- Regulatory compliance for medical devices
- Quality management system (QMS) implementation
- Regulatory submission preparation (510(k), Technical Files)
- Post-market surveillance and clinical evaluation (CER, PMCF)
Key Technologies
- Regulatory documentation authoring
- Quality systems frameworks (ISO 13485, 21 CFR Part 820)
- Audit methodologies and checklists
- Validation protocols (IQ/OQ/PQ/PPQ)
News & Updates
Interview discussing quality assurance and regulatory affairs.
Weekly blog posts on quality and regulatory affairs authored by the founder.
Authored multiple books on regulatory compliance and quality systems available through commercial book distributors.
Founder has over 40 years of experience in quality assurance and regulatory affairs and is a member of ASQ, RAPS, SME and PMI.
Interview discussing quality assurance and regulatory affairs.
Weekly blog posts on quality and regulatory affairs authored by the founder.
Authored multiple books on regulatory compliance and quality systems available through commercial book distributors.
Founder has over 40 years of experience in quality assurance and regulatory affairs and is a member of ASQ, RAPS, SME and PMI.