Quality
Quality at MDI
The effectiveness of the MDI Quality System is continuously monitored to assure that manufacturing process records are complete and accurate to meet applicable regulatory requirements and that all devices produced are of a consistently high-quality. MDI assures that all applicable regulatory & cGMP requirements are met through provision of routine Management Review, auditing, and validations. Individual sites maintain ISO and other certifications. MDI Quality will work with our contract sterilizer to develop a validated EtO sterilization cycle that fits your needs.
Certifications
Contact us to find out particular MDI manufacturing site certifications.
ISO 9001
TS 16949
ISO 13485
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