Quality Management

Harland’s Quality Management System

ISO 13485 Certificate

“We embrace Quality as a foundational principle, not merely a requirement to be met. Our Management and Employees strive to lead the medical device coating application industry by endeavoring to exceed customer and regulatory standards through meticulous self-audit and bold innovation, ever reaching for the next level in efficiency, efficacy and customer satisfaction and maintaining the effectiveness of the Quality Management System.”

-Jon Anderson, CEO May 1, 2014

Harland’s Quality Management team stands ready to support and expedite your coating programs.  All parts of Harland’s 4M Framework are operated in compliance with the ISO 13485 standards.

For a copy of our current ISO 13485 Certificate click the following button:

Regulatory Assistance

Harland has experienced in-house regulatory personnel to help advise you for effective and efficient regulatory submissions, including those involving combination drug/devices.

Device Master File access

Access to the relevant Device Master Files with the FDA can be arranged to speed your regulatory submission.   To arrange, fill in the Contact Us information to the right