Paragonix Technologies Inc., Receives ISO 13485:2003 Certification For The Paragonix Sherpa Organ Storage And Transport Systems

BRAINTREE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc. today announced it has received ISO 13485:2003 Registration and Certification for its quality management system for the design, development and manufacturing of the Paragonix Sherpa Organ Storage and Transport Systems. ISO 13485 Certification is a necessary step towards gaining European pre-market clearance for the Paragonix Sherpa Organ Storage and Transport Systems following future review of a technical file submission by the BSI Management Systems America, Inc. (BSI). The European pre-market clearance completes the Conformité Européenne (CE), or European Conformity registration process.

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