COMPOUNDING SOLUTIONS RECEIVES ISO 13485:2016 QUALITY CERTIFICATION …view
Compounding Solutions LLC, a global leader in medical plastics compounding for use in class I, II, & III medical devices, recently announced that it has received certification that the company’s quality management system complies with the requirements of ISO 13485:2016 from National Quality Assurance, U.S.A.
The ISO 13485:2016 standard is specifically designed to meet the strict quality and regulatory requirements of the medical device industry. The comprehensive ISO 13485:2016 standard includes requirements for quality management, risk management, process validation, and traceability systems.
Compounding Solutions had previously been certified to the ISO 9001:2008 standard.