{"type":"rich","version":"1.0","provider_name":"Transistor","provider_url":"https://transistor.fm","author_name":"The AI Governance Brief","title":"CRA COUNTDOWN: Who Owns This? (The Accountability Nobody Wants)","html":"<iframe width=\"100%\" height=\"180\" frameborder=\"no\" scrolling=\"no\" seamless src=\"https://share.transistor.fm/e/7d41cda4\"></iframe>","width":"100%","height":180,"duration":1762,"description":"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 ProblemCRA compliance touches eight functions—when everyone owns it, no one owns itEach function optimizes for its own objectives; no function optimizes for CRA specificallyCompetent functional performance producing collective compliance failureThe Four Accountability GapsProduct 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?The Three-Level Accountability SolutionExecutive Sponsor: Named executive accountable for compliance outcomes—resolves resource conflicts, ensures priority, provides board visibilityCRA Program Owner: Operational coordination, roadmap management, cross-functional alignment, consolidated status reportingProduct Compliance Owners: Named individual accountable for each product's conformity, documentation completeness, evidence maintenanceThe Steering Committee ModelCross-functional decision-making body, not a status meetingResolves conflicts individual...","thumbnail_url":"https://img.transistorcdn.com/rDqBMJXwlhb2bvZjH0V1qAuqxHAFqIADttstgmIyldM/rs:fill:0:0:1/w:400/h:400/q:60/mb:500000/aHR0cHM6Ly9pbWct/dXBsb2FkLXByb2R1/Y3Rpb24udHJhbnNp/c3Rvci5mbS8wNzgz/MjhlNjg0NjRjYThi/MGI3YWEzMzkyNzVm/ZTdiYy5wbmc.webp","thumbnail_width":300,"thumbnail_height":300}