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The assembly of medical devices requires intense training and experience. At the same time Operating Procedures (OP) documentation lacks user-friendly guidance for medical staff and trainees. A quality event can pose significant financial and credibility risks for payers.
Assembly instructions are not user-friendly without visual representation of work steps
Complex operating procedures cause long on-boarding of new operators
Quality System Regulation requires easy-to-follow work instructions for assembly
Every minute of changeover time is missed revenue or quality risk for a medical device or pharmaceutical company. At the same time changeover equipment is highly controlled for quality and safety reasons. This means human intervention is needed to connect manual and automated processes.
Inconsistent human intervention increases error rates and lowers product quality
Long validation and clearance times extend production downtime
Complexity of the changeover drives increased regret cost
Show the ideal state of the entire changeover procedure in a visual manner on the actual production line. Augmented instructions guide operators through each step to reduce human error and increase efficiency. Create a digital audit trail to document all steps for faster validation and clearance.
RE’FLEKT GmbH 
+49 (0) 89 122 045 10 
re‑flekt@re‑flekt.com
RE’FLEKT Inc. +1 408 744 25 50 info@re‑flekt.com