# Healthcare Device Manufacturing Security Program

> From $75K · Compliance & GRC · https://cisomarketplace.services/services/healthcare-device-manufacturing

Comprehensive security assessment for medical device manufacturers, covering FDA compliance, manufacturing processes, and device security throughout the development lifecycle.

## In scope

- Manufacturing process security
- FDA compliance review
- Device firmware security
- Supply chain validation
- Quality control systems assessment
- Development lifecycle security

## Deliverables

- Manufacturing security architecture
- FDA compliance documentation
- Security controls matrix
- Supply chain security framework
- Device security guidelines
- Secure SDLC implementation

## Tiers

### Core Manufacturing Security Assessment: $75K

Assessment for 1 device product line, 1 manufacturing site and up to 10 suppliers: manufacturing process security review, FDA cybersecurity requirements gap review, firmware security design review, quality system and development lifecycle review. Report and controls matrix.

Limits: devices 1, locations 1, vendors 10

Includes:
- Manufacturing process security review of 1 site
- FDA cybersecurity requirements gap review
- Firmware security design review for 1 product line
- Supply chain review for up to 10 suppliers
- Security controls matrix and device security guidelines

Excludes:
- Hands-on firmware or device penetration testing
- Writing FDA submission documentation
- Secure SDLC implementation
- Additional product lines or sites

### Advanced Manufacturing Security Program: $125K

Comprehensive program including detailed process validation and complete security implementation

Limits: devices 3, locations 2, vendors 25

Excludes:
- Hands-on device penetration testing
- Ongoing compliance management
- Custom tooling

### Enterprise Manufacturing Security Solution: $200K

Full-scope manufacturing security with custom tools, continuous monitoring, and complete compliance management

Limits: devices 6, locations 5, vendors 60

Excludes:
- Hands-on device penetration testing (separate service)
- FDA submission filing or regulatory representation
- Tool licences and production hardware

## Terms

Starting price shown is the lowest published tier. A written proposal fixes scope, tier and price before anything is signed. Timeline is set in the SOW.

Scope this engagement: https://cisomarketplace.services/scope?service=healthcare-device-manufacturing