Complete approval process included:

• Qualification
• Classification
• Approval strategy
• Post Market Surveillance
  

• Sample processes
• GAP analyses   
• ISMS
• Audits

Project planning

Pre-configured project plans for:

• QM processes
• Technical documentation
• Approvals
• Audits

FDA

Development of the US market including:

• FDA Inspection
• Cybersecurity
• MOCK Audits