AKRON—Akron Rubber Development Laboratory Inc. has received an additional ISO certification for testing of medical and biopharmaceutical devices, allowing the company a greater range of services for analysis.
Known as ISO 13485:2016, the certification ensures "consistency in the quality control and assurance process for medical device manufacturing and service industries," ARDL said in a recent press release.
These services can be applied to Class I, II and III medical products, including medical gloves, hospital gowns, surgical gloves and facemasks, as well as many other more complex products.
"The challenges faced by medical device manufacturers increase daily and ARDL has implemented certification requirements to help customers meet their regulatory goals," the company said.
ARDL can assist customers from the beginning of project testing—based on product batch size—to final reporting on the device, assessing risk throughout the process to avoid future problems.
In addition, ARDL's quality control operations manages records and conducts audits, training and competency reviews of the analysis and medical device products. The company works with customers to improve the development of processes and equipment.
"ARDL follows a strict management and quality system including order review, document control, supplier qualification, part verification, lot identification and traceability, process control, process and software validations, inspection and testing status," the company said.