Tag

#Change control

QMS / ISO 13485 Published 2026.09.19 Notification of Supplier Change: Records to Keep After Receiving the Email This practical guide connects the scope of changes, review basis, and applicable lots in a fictitious case of changing manufacturing location.
It contains practical questions and checklists to convert the supplier’s explanation into our product judgment records.
Risk management & safety Published 2026.09.11 Medical Device Risk Management, What Should Follow the Analysis Table? We look at the practical tasks that remain after creating a risk management table.
From distinguishing risk factors and risk situations to the basis for control measures and connecting change and complaint records, explanations are provided with hypothetical examples.
QMS / ISO 13485 Published 2026.09.11 Maintaining a Quality System: Connecting Procedures with Actual Work What should be checked first when quality system documents exist but do not match actual operations? This article suggests practical methods for verifying the connection between procedures, responsibilities, records, and review results by following a single change task.
Regulatory software Published 2026.08.23 Lessons Learned in Translating Regulatory Judgments into Software: A Record of Q-Atelier Engine Design Real issues encountered when coding regulatory requirements as rules.
This record organizes the design of a system that conducts judgments outside the engine, which addresses reproducibility, rule versioning, and expert calibration.