Medical Device Consulting

Regulatory Affairs and Quality Management

With our offices in the U.S. and Germany, we support you with expertise and years of experience in meeting the regulatory requirements for quality management, product development, risk management, validation, GMP, documentation and approval.

Quality Management Quality
Management

  • Quality Systems
  • ISO 13485 and 9001
  • FDA QSR
  • SOPs and Quality Manual
  • Audits
  • Training

Regulatory AffairsRegulatory
Affairs

  • 510k Submissions
  • FDA Registration
  • FDA Agent
  • FDA Inspections
  • Audit Preparation
  • CE marking

Our ServicesOur
Services

  • Project Management
  • Risk Analysis
  • Qualification
  • Process Validation
  • Cleaning Validation
  • Software Validation