ISO 13485 §4.1.6 doesn't grade on operator experience. QmsWrapper Foundation at €3,499/yr, uncapped users, validated workflows outlast the learning curve.

#MedTech #AuditReady #ProcessValidation

Templates save time. They don't save you from thinking.

#ISO13485 #DocumentControl #ProcessValidation

murphy and Ollie don't scale by adding more terriers, you scale by what you teach them. Foundation works the same: uncapped users, priced by capability, not headcount. Beyond that, it's a quote.

#MedicalDeviceQMS #ProcessValidation #CAPA

Endoscopy robot just got fda clearance. "robot" sounds futuristic but the 62304 validation surface just tripled, every motion controller, vision pipeline, failsafe needs evidence. Trend's real, paperwork isn't optional.

#MedTech #ProcessValidation #FDACompliance

Convenience kits with known sterility breaches should never have shipped. Full stop. 📋

#DeviationManagement #ProcessValidation #MedTech