The cost of ISO 13485 consulting can vary widely depending on several factors, including the scope of the project, the size and complexity of your organization, the level of expertise of the consultant, and the geographic location. Here are some general price ranges:

1. Hourly Rates:

Consultants might charge between $100 to $300 per hour. Highly experienced consultants or those with specialized expertise might charge more.

2. Project-Based Fees:

For a comprehensive ISO 13485 implementation project, the total cost could range from $10,000 to $100,000 or more. This depends on the depth of the engagement and the specific needs of the organization.

3. Retainer Fees:

Some consultants work on a retainer basis, which might range from $2,000 to $10,000 per month, providing ongoing support and services.

4. Training and Workshops:

Costs for training sessions and workshops can range from $500 to $2,000 per session. Custom training tailored to the organization’s needs might be more expensive.

5. Pre-Audit and Gap Analysis:

A pre-audit or gap analysis, where the consultant assesses the current state of compliance and identifies gaps, might cost between $5,000 to $15,000.

6. Certification Preparation Packages:

Some consultants offer packages that include everything from initial assessment to final certification, with prices typically ranging from $20,000 to $80,000.

When considering hiring an ISO 13485 consultant, it's important to get detailed proposals from several consultants to compare their services, experience, and pricing. Also, ensure that the consultant has specific experience with ISO 13485, as this standard has unique requirements for medical device quality management systems.