Quality Consulting and Regulatory Compliance Consulting

Our Quality and Regulatory Compliance solutions are customized to your specific needs.  We can give your staff the information they need to deliver your customized solution, or augment your staff (from associate to executive level), to meet your goals/objectives.  Solutions and areas of expertise include, but are not limited to:

• Quality Systems
  • Design, Development, Implementation, Execution, and Optimization (entire system or specific sub-system(s))
  • CAPA Planning and Execution
• Design Control Execution Support
  • Design and Development Planning through Design Transfer
  • Design Verification and Validation
  • Risk Analysis and Risk Management (ISO 14971)
  • Embedded and Standalone Software (IEC 62304)
  • Human Factors and Usability Engineering (IEC 62366)
  • Combination Products
  • Digital Therapeutics
• Process Optimization and Validation
  • Lean Manufacturing and Six Sigma Optimization
  • Verification and Validation
  • Implementation of manufacturing and supply
  • Manufacturing and Quality System Software
  • Sterilization Validation
    • EtO, Gamma, Electron Beam, Moist Heat
  • Cleaning and Packaging Validation
• Didactic Training Sessions
  • Quality System (FDA, EU, MDSAP)
  • Design Control and Risk Management
  • Verification and Validation
  • CAPA
  • Handling Regulatory Inspections
  • EU MDR 2017/745 / EU IVDR 2017/746
  • 21 CFR Part 11
  • Combination Products (21 CFR Part 4)
• Regulatory Compliance/Auditing
  • GAP Assessments
    • Quality System: 21 CFR Part 4, 210, 211, 820, 1271, MDSAP, ISO 13485 Certification
    • 21 CFR Part 11
    • Product Design and Development (incl. Software)
    • CAP and CLIA
  • Mock Audits/Inspections
    • FDA
    • MDSAP
    • ISO 13485
    • EU MDR 2017/745 / EU IVDR 2017/746
  • Due Diligence Assessments
    • Quality System (full or partial)
    • Product Design and Development
  • Inspection/Audit Management and Support
    • Facility/Systems Inspection Readiness
    • FDA Inspections
    • MDSAP Audits
    • ISO 13485 Audits
  • Remediation
    • Response Strategies and Response Documentation Preparation (FDA Form 483, Untitled Letter, Warning Letter, and Order to Cease Manufacturing, etc.)
    • Quality System Compliance Remediation (entire system or specific sub-system(s))
    • Product DHF/Medical Device File/Technical File Remediation
    • Product Recall and Corrective Action Strategy and Execution
  • General Auditing
    • Supplier Quality (full program or single audit)
    • Internal Audit (full program or single audit)
    • Supplier Selection
    • Manufacturing Process/Facility Review