Services

International Activities
Diligence
Start-up Services
Pre-Market Services
Manufacturing/Post-Market
Special Areas of Expertise

Manufacturing and Post-Market Regulatory Consulting

  • Quality System implementation to meet ISO 13485 and FDA QSR requirements
  • Process Validation
  • Complaint Handling procedures and implementation
  • FDA 483 Responses and Crisis Management, including Recalls
  • Quality System Auditing (to CMDCAS, ISO 13485, FDA QSR)
  • Manufacturer Registrations and Device Listings