Demonstrating the company’s never-ending commitment to quality, the Puerto Rico facility has become the first within CooperVision to earn a Medical Device Single Audit Program (MDSAP) certification.
Developed by a forward-looking group of medical device regulators, MDSAP allows participating auditing organizations to conduct a single audit of a Medical Device Quality Management System, replacing multiple separate audits that have been required for ongoing operation. Currently voluntary for markets including the U.S., Japan, Brazil and Australia, MDSAP will become mandatory for regulatory submissions in Canada beginning next year.
Experience gained in Juana Diaz during past regulatory visits facilitated the readiness process. Preparation spanned nearly one year, combining significant communication, planning and scheduling, as well as comparing company processes to forthcoming requirements.
“This is a significant milestone and could not have been done without our strong compliance culture, living of the CooperVision values, commitment, dedication and hard work of everyone in Puerto Rico,” said Javier Pellicier, Plant Manager, Puerto Rico Manufacturing Operations.
MDSAP certification will now reduce the overall number of audits and associated time spent on each, accelerate product entry into select geographic markets and ultimately contribute to the global growth of the business.
The CooperVision Costa Rica plant also recently earned its MDSAP designation. All CooperVision manufacturing sites are intended to become MDSAP-certified, in concert with ongoing quality management initiatives.
“This accomplishment positions ourselves for optimal compliance in a global regulatory environment and proves we can successfully meet other challenges in the future,” noted Norma Casanova, Director, Quality Assurance & Regulatory Control.