expert – sustainable – affordable

Medical Device and Pharmaceutical industry veterans are ready to help you comply with FDA and ISO 13485 requirements.

  • Certified ISO13485:2016 Lead Auditor
  • Quality Assurance Systems; Quality Manuals; SOPs
  • Master Validation Plans: Process Validation support
  • Independent Compliance Audits
  •  510(k) preparation
  • EU MDR Technical File Preparation Support
  • US Agent Services
  • Response to FDA 483 / Warning Letters
  • Remediation Plans