Chris WareFor some audits, STOP READING and START TALKINGI wasn’t getting anywhere. It was Wednesday afternoon and I’d spent the last three days leading an internal audit of a Korean medical…Jun 7, 2023Jun 7, 2023
Chris WareThe Pre-Audit: Key Technique for Excellent MedTech Internal AuditsFDA wrote the book on how to perform audits of medical device companies. Literally, the book Guide to Inspection of Quality Systems —…May 31, 2023May 31, 2023
Chris WareBe Right, Be FastToday Ford announced the reversal of a significant product decision: they will be putting AM radios back into their vehicles. Digging into…May 24, 2023May 24, 2023
Chris WareAre you *sure* you need FDA approval?For anyone building products in the healthcare world, it’s healthy to begin with the assumption that that your product will require FDA…May 17, 2023May 17, 2023
Chris Ware“How-to” versus “why”My default information consumption paradigm is “results-based learning”. This is when I’m faced with a decision to be made or an action to…May 3, 2023May 3, 2023
Chris WareQuality Criteria Architecture for Medical SoftwareThis is my mental model for setting up the quality criteria for medical software products. It does a good job bridging from strategic…Apr 19, 2023Apr 19, 2023
Chris WareFDA CurveballsI keep a close eye on the FDA — when you’re developing healthcare products, it’s important to keep up to date with the regulatory…Apr 12, 20231Apr 12, 20231
Chris WareHealthcare Technology BusineThe commercial landscape for healthcare technology continues to evolve. The excitement around purely digital health offerings has cooled…Apr 4, 2023Apr 4, 2023
Chris WareMedtech CybersecurityCybersecurity is critical to anyone in the medtech space. Whether you’re manufacturing a hip implant using an automated assembly line…Mar 29, 2023Mar 29, 2023