Carlos C Cruz (3C)

Regulatory clarity for medical device companies that can’t afford surprises.

I work with founders, executives, and investors to reduce regulatory, quality, and commercialization risk before it becomes expensive.

The Problem

Medical device companies rarely fail because of a single mistake.
They fail because of unseen risk, unclear ownership, and decisions made too late.

Common issues include:

• Quality systems built too fast or without discipline

• Suppliers operating without effective oversight

• Regulatory assumptions that do not hold up under inspection

• Commercial timelines disconnected from compliance reality
  
  

My role is to identify these risks early and address them directly.

What I Do

Regulatory and Quality Systems

• FDA and ISO 13485–aligned QMS development

• Inspection readiness and gap remediation

• Supplier qualification and oversight

• Practical risk management systems
  
  

Commercialization Support

• Design transfer and manufacturing scale-up

• Process validation strategy

• Quality infrastructure that supports growth
  
  

Executive and Investor Advisory

• Independent regulatory and operational assessment

• Due diligence support

• Interim quality and operations leadership

How I Work

I work with leadership teams that value:

• Clear thinking over speed

• Evidence over optimism

• Fewer decisions made correctly
  
  

My approach is:

• Structured and direct

• Focused on reducing uncertainty

• Aligned with how regulators actually evaluate companies

If something does not matter to regulators or auditors, I do not recommend building it.

Typical Engagements

• Early-stage medical device companies preparing for FDA interaction

• Established companies correcting quality system drift

• Investors assessing regulatory and operational risk

• Executives seeking experienced, independent judgment

Background

I have over 25 years of experience in medical device engineering, quality systems, and manufacturing operations.

I have supported products from early development through commercialization, FDA inspection, and scale-up.

My focus is not on selling services. It is on helping leadership avoid avoidable mistakes.

Contact

If you are evaluating regulatory risk, quality system readiness, or commercialization strategy, you can email me at: Carlos@CarlosCCruz.com with your:

Name
Company
Role
Brief description of the situation