​Quality

 

APL Manufacturing is currently in the process of implementing an ISO 13485:2016 quality management system (target completion Q2 2025). 

 

ISO 13485 has its roots in ISO 9001, but includes some more specific and stringent requirements to meet the strict regulatory needs of the medical device industry.

 

With a background in medical device development and  manufacture, we believe that all high-tech products benefit from production under the ISO 13485 QMS.