A Hospital Group Just Asked What You Do When Your AI Diagnostic Tool Stops Meeting Accuracy Benchmarks Mid-Contract: Answering the Article 21 Corrective Actions Section The vendor review came eighteen months into the contract. A regional hospital gro...
A hospital network procurement team just sent you a 40-question AI governance questionnaire. One section is headed "Serious Incident Reporting and Post-Market Obligations." The first question reads: "Does your AI system have a documented process for ...
It started with one email. A 1,600-bed academic medical center in the Netherlands was evaluating your AI-assisted clinical decision support tool. Six weeks into procurement, their medical devices procurement officer sent a 58-question MDR compliance ...
A Hospital Just Added 14 New Questions to Your Vendor Questionnaire: How to Answer the Article 72 Post-Market Monitoring Section The update came by email on a Tuesday. Your healthtech company had submitted a vendor questionnaire to a 900-bed academic...
The questionnaire arrived from a 1,400-bed teaching hospital in Belgium. Section 4 had a single, brutal question: "Describe the training data used for your AI clinical decision support tool. Specify the patient population represented, the geographic ...
A healthtech founder I spoke with last week had closed a six-figure deal with a Dutch hospital network in January. In April, the hospital's procurement office sent a renewal packet. Included was a new twelve-page annex titled "AI Act Conformity — Pro...