I recently facilitated a CRA readiness meeting with a mid-size medical technology company. Present: the CISO, the VP of Engineering, the Chief Product Officer, the General Counsel, and the VP of Quality Assurance. I asked a simple question: "Who owns CRA compliance for your flagship monitoring platform?" Forty-five seconds of silence. Then the CISO said, "I assumed Product owned it." The CPO said, "We thought it was a security matter." The VP of Engineering said, "Legal never told us it was our responsibility." The General Counsel said, "We've been waiting for someone to tell us what Legal's role should be."

That platform ships to thirty-two EU countries. Nobody owns its compliance.

In This Episode:

• The Accountability Diffusion Problem
  • CRA compliance touches eight functions—when everyone owns it, no one owns it
  • Each function optimizes for its own objectives; no function optimizes for CRA specifically
  • Competent functional performance producing collective compliance failure
• The Four Accountability Gaps
  • Product lifecycle ownership discontinuity: who owns the product across 5+ years of support?
  • Cross-functional requirement translation: who converts CRA language into engineering specs, test cases, documentation requirements?
  • Evidence aggregation: who integrates outputs from multiple functions into examination-ready packages?
  • Conformity declaration authority: who signs, and do they have visibility into actual compliance status?
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• The Three-Level Accountability Solution
  • Executive Sponsor: Named executive accountable for compliance outcomes—resolves resource conflicts, ensures priority, provides board visibility
  • CRA Program Owner: Operational coordination, roadmap management, cross-functional alignment, consolidated status reporting
  • Product Compliance Owners: Named individual accountable for each product's conformity, documentation completeness, evidence maintenance
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• The Steering Committee Model
  • Cross-functional decision-making body, not a status meeting
  • Resolves conflicts individual functions cannot resolve alone
  • Weekly during implementation, bi-weekly during steady state
  • Chaired by Program Owner, executive sponsor attends monthly
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• The RACI Framework
  • Product inventory: Product Management (R), Program Owner (A)
  • Risk assessment: IT Security (R), Product Compliance Owner (A)
  • SBOM generation: Engineering (R), Product Compliance Owner (A)
  • Technical documentation: Engineering/Tech Writing (R), Product Compliance Owner (A)
  • Conformity testing: Quality Assurance (R), Product Compliance Owner (A)
  • EU Declaration of Conformity: Legal (R), Executive Sponsor (A)
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• Five Governance Pitfalls to Avoid
  • Assigning ownership without authority
  • Over-centralizing execution (creates bottlenecks)
  • Treating CISO as default owner (CRA is product safety, not just security)
  • Failing to define product-level owners
  • Governance without executive commitment

Your Fourteen-Day Action Plan:

Days 1-3: Confirm executive sponsorship with explicit CEO/executive team discussion Days 4-6: Identify/appoint CRA Program Owner with defined authority Days 7-9: Form Steering Committee, define membership and meeting cadence Days 10-12: Assign Product Compliance Owners for every in-scope product Days 13-14: Develop RACI matrix for key CRA activities

Deliverables:

1. Documented executive sponsorship
2. Appointed Program Owner with defined authority
3. Formed Steering Committee with scheduled meetings
4. Assigned Product Compliance Owners for all in-scope products
5. RACI matrix defining cross-functional accountability

Ready to establish CRA governance?

The First Witness Stress Test includes governance assessment—identifying accountability gaps, mapping current ownership patterns, and recommending structures that convert functional activity into compliance outcomes. Stop assuming someone owns it. Start documenting who does.

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