Quality Systems:
Remmele Medical Device | El-Tronic’s quality systems are ISO 13485/9001 registered. Their quality systems were established in compliance with the following U.S. and International quality standards, guidelines and directives:
- ISO 13485:2003
- ISO 9001:2008
- Meet industry recommendations for machine-tool calibration
Remmele partners with its customers at every stage of the design, development and qualification process. Their quality engineers support customers’ process validation, DOE, FAI, IQ, OQ, and PQ requirements from design for manufacturability input to delivery. Remmele’s demonstrated quality performance has enabled it to achieve certified supplier and/ or “ship-to-stock” status with a number of customers in the medical device industry.