Services

Auditing:
  • Internal Auditing
  • Supplier Audits
  • FDA Readiness Mock Inspections
  • Due diligence audits
Project Management
  • Temporary QMS Support (Hands on)
  • QMS Mergers (acquisitions)
  • Product and Quality System Standard Implementation
Quality Management System Support
  • Outsourcing alternative (Interim Management, Short-term Staffing)
  • Supplier Audits
  • Procedure Development and Implementation
  • Development of new Quality Management Systems
  • QMS System upgrade
  • QMS evaluation/assessment
Quality Management System Development
  • ISO 9001
  • ISO 13485
  • 21CFR820
  • 21CFR210 & 211
  • PAL
  • ISO 14155
  • EN ISO 14971
  • ISO 14000
  • CMDCAS
FDA Enforcement Support
  • 483 Warning Letter Response
  • FDA Investigation Preparation
Training
  • Internal Auditor
  • Quality Management System Overview
  • Training on Standard Requirements
  • Risk Management
CE-Marking
  • MDD
  • AIMD
  • IVDD
  • Technical File/Dossier Development
  • Notified Body facilitation
Improvement
  • Lean
  • Problem Solving (8-D)
  • 6 Sigma
  • Teaming
  • Empowerment
  • Total Quality Management
  • Statistical Process Control