ISO 13485 Audit Ensures DeviceLab’s Medical Device Design and Manufacturing Meets Quality Management System Standards
ORANGE COUNTY, Calif., July 3—DeviceLab Inc., an Orange County medical device design and manufacturing company, today announced it has completed a three-day audit that enables renewal of its ISO 13485 certification.
First granted in 2012, this is the fifth time DeviceLab has successfully renewed its ISO 13485 certification.
As defined by the International Organization for Standardization, ISO 13485 is a standard that specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
Every five years, a thorough ISO 13485 audit by an independent notified body must be conducted. DeviceLab’s ISO 13485 certification audit was performed by BSI.
“We are pleased the ISO 13485 audit is complete,” said DeviceLab founder and CEO Dac Vu. “Being able to renew our ISO 13485 certification validates the confidence our customers have in our proficiencies with efficiently developing safe and reliable medical devices—especially now that we are increasingly practicing in the wearable medical device and healthcare IoT space.”
DeviceLab is an ISO-13485 certified medical device development company that has completed more than 100 medical device design projects of varying complexity—including medical device software development and wireless medical device design services for the newest breeds of medical IoT, mHealth and medical wearables.
For more information about DeviceLab, please visit devicelab.com.