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Clean room photo

Coeur, Inc. partners with leading industry experts to ensure sterility assurance and regulatory compliance. We can meet our customers’ compliance needs for AAMI\ANSI\ISO 11135 and EN550 requirements.

Coeur, Inc. guides our clients through the sterilization process:

We also maintain documentation to support regulatory compliance.

All of these services are within an ISO 9000:2000/ISO 13485:2003 certified location.