New Market Requirements Inspire ISO13485:2016 Certification
NORTHBROOK, Ill. (June 1, 2022) — As healthcare industries begin to require International Organization for Standardization (ISO) certification from their medical device manufacturers, MinXray Inc., a key global supplier of portable, compact digital imaging equipment, announced that it earned ISO13485:2016 Certification on April, 21, 2022. The certification ensures compliance with internationally recognized best practices and safety protocols.
ISO 13485 is a Quality Management System for medical device/component manufacturers. This includes any organization that designs, produces, installs, or services medical devices and components. As a globally recognized standard, ISO 13485:2016 makes product conformity possible amidst expanding international supply chains.
Due to the vital nature of these products, conformity is paramount for reducing risk and increasing customer satisfaction. To earn the certificate, MinXray had to demonstrate to a third-party registrar via certification audit that its quality assurance processes consistently provide devices that meet both customer requests and applicable regulatory requirements.
MinXray’s Director of Technical and Customer Support, Ed Dubbs commented MinXray was already doing well before for audit, saying, “We had the details and data required to document adherence to regulatory codes. The audit and subsequent certification gave us added insight into our company’s conformance.”
Moving forward, MinXray’s certification will help its business stand out and grow in the industries that require ISO compliance. MinXray continues to see development internally as well, with Dubbs stating, “The challenge now is to keep MinXray focused on what we do well while being mindful of our deeper understanding of who we are and how we can be better.”