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Articles Tagged "iso 9001"

Flex-Cell Precision Gains ISO 13485:2016/9001:2015 Certifications

by BONEZONE | Oct 2018

Flex-Cell is a contract manufacturer of orthopaedic implants and surgical components.... Read more »

United Performance Metals Achieves ISO 9001:2015 Certification

by BONEZONE | Feb 2018

Companies use the standard to demonstrate their ability to manage, monitor and consistently provide quality products and services.... Read more »

Medilogic Gains ISO 13485/9001 Certifications

by BONEZONE | Jan 2018

The company specializes in CNC precision manufacturing.... Read more »

Autocam Medical’s Massachusetts Facility Recertified to ISO 13485:2016

by BONEZONE | Oct 2017

The recertification represents the company's continued investment in its quality management system... Read more »

The Revitalized ISO 13485: Ready for Business

by BONEZONE | Feb 2016

The ISO 13485:2016 Standard is slated for publication in March 2016. Consider these eight changes when updating your certification.The internationally-recognized medical device industry quality management systems (QMS) standard has been under revision since 2010. The newest version of ISO 13485 (201... Read more »

ISO 9001 Drastically Revised

by Robert Packard | Aug 2015

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Cadence Facility Receives 13485:2012 and ISO 9001:2008 Certification

by BONEZONE | Jun 2013

Cadence, a provider of medical device outsourcing solutions, received ISO 13485:2012 and ISO 9001:2008 certification through BSI for its Pittsburgh, Pennsylvania location.  Cadence's new facility offers turnkey finished medical device assembly and sterilization management capabilities, allowin... Read more »