Medical Device Consulting

Regulatory Affairs and Quality Management

We support you with expertise and years of experience in meeting the Medical Device regulatory requirements for quality management, product development, risk management, validation, documentation and approval.

Quality Management Quality
Management

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

Regulatory AffairsRegulatory
Affairs

  • 510k Submissions
  • FDA Inspections
  • Audit Preparation
  • CE marking (MDR)
  • MDSAP

Our ServicesOur
Services

  • Project Management
  • Technical Documentation (MDR)
  • Risk Analysis
  • Clinical Evaluations
  • Postmarket Surveillance