Cosmed Group, Inc. is pleased to announce that our facility in Erie, PA d/b/a Cosmed of PA, recently achieved BSI accredited certification to ISO13485:2016 and ISO 11135:2014. Cosmed Group is among the earliest companies to receive certification to the most recent version of ISO 13485.

You may download a copy of the certification here.

ISO 13485 provides requirements for a quality management system for the design and manufacture of medical devices. Prior to the recent acquisition, the Erie facility

complied with the earlier version of the standard. Following a comprehensive update to the quality system, the facility achieved compliance with the more rigorous ISO 13485:2016. This achievement confirms Cosmed Group’s forward thinking approach to quality system management and our efforts toward continuous improvement.

The standard providing for the development, validation and routine control of a sterilization process for medical devices, EN ISO 11135:2014, provides comprehensive requirements for contract sterilization facilities. The Certificate of Registration includes an endorsement of the facility’s compliance with the provisions of this important standard.

For more information about the Cosmed Group’s sterilization capabilities please contact Clark Houghtling, VP Business Development & Technical Affairs.

clarkh@cosmedgroup.com
(585) 698-6342