Services

ADVISING, FORECASTING, PLANNING

Regulatory & Quality Services

• Plan strategically from design to market
• Identify the regulatory requirements for medical and IVD devices and provide advice and services for compliance
• Prepare and assist clients in regulatory submissions, manufacturing compliance, quality system implementation, and other regulatory requirements for most Class I & Class II devices.

Fee Structure

The CMI Regulatory Consulting Center offers two methods of payment:

Fee for service

• Appropriate for short-term consultations
• Billed on an hourly basis, usually upon completion of work

Contractual agreements

• Appropriate for long-term projects
• Invoiced on a monthly basis