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

Fee for Service

U of U Affiliates

Outside Community

Initial Consultation

Free/ 1st hr

Free/ 1st hr

Faculty Consultation

$60/hr

$100/hr

Student/Associate Support

$30/hr

$50/hr


Contractual Service Structure w/ Estimated Associated Costs

Service Type

Hourly/ Fee

(U of U Affiliates)

(Non-U of U)

FDA Regulatory Support

Traditional 510(k) Submission

Fee

$5,000

$12,000

Special 510(k) Submission

Fee

$2,500

$8,000

FDA Class 1 – JTF Package Deal

Fee

$1,750

$3,500

510(k) – De Novo

Fee

$8,000

$15,000

Regulatory Pathway Assessment/Predicate Search

Fee

$300

$500

Annual Establishment Registration

Each time

$300

$600

EU Regulatory Support

Tech File (Class 1 & 2a) Submission

Fee

$5,000

$12,000

Design Dossier (Class 2b & 3)

Fee

$6,000

$15,000

EU Pathway Assessment

Fee

$300

$500

Clinical Evaluation Report (CER)

Fee

$4,000

$10,000

Marketing Doc review

Hourly

$60 p/hr

$100 p/hr

Labeling Creation/ Review

Hourly

$60 p/hr

$100 p/hr

Write QMS System

-    13485 & 21 CFR 820

~40 - 60 SOP’s

$5,000

$9,000

-    21 CFR 820 Only

~20 - 36 SOP’s

$4,200

$8,000

-    FDA GMP Exempt QSR

~3-8 Sop’s

$1,200

$1,600

Additional Work (as necessary) may include but not limited to: Consulting, Meetings, Communications, Other documentation requirements, Design and Development Assistance, FMEA creation/ review, Audits, Auditing, etc.

$60 p/hr

$100 p/hr