Devices for US

• Device Master Files (MAFs)
• 510(k)
• Special 510(k)
• PMA
• Amendments to PMAs
• Supplements
• Device Listings
• Establishment Listings
• Preparation of facilities for Pre-Approval Inspections
• Assistance during the Inspection(s)
• Advice on how to handle changes to approved or cleared devices
• Preparation of SOPs and Quality Manuals compliant with QSRs
• Assistance in Adverse Event reporting and recalls

Devices for Non-US

• Preparation and filing of various classes of devices in:
  • Canada
  • South America
  • Central America
  • EU states
  • Non-EU countries
• Preparing clients for inspections by notified bodies:
  • ISO 9000
  • EN 13485
  • For CE marks
  • For Canadian notified body certification (CMDCAS)