Regulatory Consulting

Navigate Compliance with Confidence

FDA, HIPAA, NIST, FedRAMP—we speak the language of regulators. Our consulting team brings decades of experience helping healthcare, MedTech, and government organizations achieve and maintain compliance.

Regulatory frameworks we specialize in

FDA 21 CFR Part 820
Quality System Regulation
ISO 13485
Medical Device QMS
ISO 14971
Risk Management
IEC 62304
Software Lifecycle
HIPAA
Healthcare Privacy
NIST 800-53
Federal Security
FedRAMP
Cloud Authorization
SOC 2
Service Organization Controls

Consulting Services

Comprehensive regulatory consulting to help you navigate complex compliance requirements

FDA Regulatory Strategy

Navigate the FDA submission process with confidence. We help you develop regulatory strategies for 510(k), PMA, and De Novo pathways.

  • 510(k) Submission Strategy
  • Pre-submission Meetings
  • Clinical Trial Design
  • Post-Market Surveillance

HIPAA Compliance

Comprehensive HIPAA compliance programs including risk assessments, policy development, and ongoing monitoring.

  • Risk Assessments
  • Policy & Procedure Development
  • Training Programs
  • Breach Response Planning

Quality Management Systems

Design and implement QMS frameworks that meet FDA 21 CFR Part 820 and ISO 13485 requirements.

  • QMS Design & Implementation
  • CAPA Processes
  • Document Control
  • Internal Audits

NIST & FedRAMP

Federal compliance programs for government contractors and agencies, including NIST 800-53 and FedRAMP authorization.

  • NIST Framework Implementation
  • FedRAMP Authorization
  • Continuous Monitoring
  • Security Documentation

Risk Management

Systematic approaches to identifying, assessing, and mitigating risks throughout the product lifecycle.

  • ISO 14971 Risk Analysis
  • Hazard Analysis
  • Risk Mitigation Strategies
  • Risk-Benefit Analysis

Technical Documentation

Regulatory-ready documentation that satisfies FDA, ISO, and federal requirements.

  • Design History Files
  • Technical Files
  • User Documentation
  • Labeling Requirements

Why Choose Our Consulting Team

27+ years of experience in regulated industries
Former FDA reviewers and industry experts on staff
100+ successful regulatory submissions
Deep understanding of both technology and compliance
Practical, actionable guidance—not just theory
Long-term partnership approach to compliance

Ready to Simplify Compliance?

Let our regulatory experts help you navigate the path to approval and ongoing compliance.