Navigate Regulatory Compliance with Confidence
Comprehensive Compliance Solutions
Expert services tailored to your regulatory and quality management needs
- Document Control Systems
- Change Control Management
- Version Control & Traceability
- Records Management
- Compliance Quest
- Omnify
- ComplianceWire
- Agile & CATSWeb
- FDA Quality Systems
- ISO 13485 & ISO 9001
- ISO 15189 & CAP
- MDD & ICH E6
- Internal Audits
- Supplier Audits
- FDA Audit Support
- Notified Body Audits
- Staff Training Programs
- Compliance Education
- Technical Skills Development
- Team Mentoring
- Supplier Management
- Incoming QA Inspection
- Audit Program
- Calibration Program
- CAPA and NC
Industries We Serve
Deep expertise in highly regulated life sciences sectors
Marissa Runes
Associate Director, Document Control & Quality Systems
With over two decades of progressive experience in highly regulated industries, Marissa brings unparalleled expertise in document control, quality systems, and regulatory compliance to life sciences and medical device companies.
Having supported 400+ users as a subject matter expert and successfully implemented multiple eQMS platforms including Compliance Quest, Omnify, ComplianceWire, Agile, and Arena, Marissa delivers proven solutions in regulatory compliance, Training Management, and operational efficiency.
Core Expertise
Proven Track Record of Excellence
Delivering results for life sciences and medical device companies
Why Choose Runes Compliance Consulting
Partner with a leader in regulatory compliance and quality management
Proven Expertise
20+ years of progressive experience in document control and quality systems across multiple highly regulated industries.
Regulatory Excellence
Deep knowledge of FDA, ISO 13485, ISO 9001, CAP, and international standards with a 100% audit success rate.
eQMS Mastery
Subject matter expert in Compliance Quest, Omnify, ComplianceWire, Agile, and other leading quality management systems.
Team Development
Proven track record in building, leading, and mentoring high-performing document control and quality teams.
Results-Driven
Supported 400+ users, implemented multiple eQMS platforms, and consistently delivered measurable improvements.
Continuous Improvement
Data-driven approach to quality management, leveraging statistical analysis and trend monitoring for ongoing optimization.
How We Work With You
A proven methodology for achieving and maintaining regulatory compliance
Discovery & Assessment
We begin by understanding your current compliance status, quality systems, and specific regulatory requirements. Through comprehensive assessment, we identify gaps and opportunities for improvement.
Strategic Planning
Develop a customized compliance roadmap tailored to your organization. We prioritize initiatives based on regulatory deadlines, risk levels, and business objectives.
Implementation
Execute the plan with precision. Whether implementing an eQMS, establishing document control systems, or preparing for audits, we ensure seamless integration with your operations.
Training & Support
Empower your team with comprehensive training programs. We provide ongoing support to ensure sustained compliance and continuous improvement.
Monitoring & Optimization
Track performance metrics, conduct regular audits, and optimize processes. We help you maintain compliance while driving operational efficiency.
Start Your Compliance Journey Today
Partner with an industry leader who understands the complexities of regulatory compliance. Schedule a free consultation to discuss your specific needs.
No obligation • Free initial consultation • Confidential discussion
Ready to Ensure Compliance?
Let's discuss how we can support your regulatory and quality management needs
Quick Response
We typically respond to all inquiries within 24 hours. For urgent matters, please call us directly.