MinXray Affirms Quality of Its Medical Devices with ISO Certification

New Market Requirements Inspire ISO13485:2016 Certification

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 that MinXray was already doing well before the 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.”


Other diagnostic imaging news can be found here.

SourceMinXray
Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

Building on its ZEISS Medical Ecosystem, several of the new innovations enable seamless data integration and management across the cataract and refractive workflows, creating a new standard for efficient, personalized ophthalmic care.
MinXray MinXray, a leading manufacturer of imaging systems for medical and veterinary use, recently sent its Impact Wireless X-ray system with a group of researchers...
New supply contract to bring Lunit INSIGHT CXR to TeleDiag in France and Lunit INSIGHT MMG to the Central region branch of the Portuguese League Against Cancer
KA Imaging reported a collection of positive metrics to its stakeholders, with revenue four times larger than that of the previous year and a 38% growth in headcount in 2023. The positive trend continues to be observed in Q1 2024.
Isaac Zaworski, President of Sectra advises: "Collaborating across sites and providing efficient radiology workflows are needed to cope with the increasing imaging volumes. This new customer is the 60th healthcare provider to use Sectra in the US Midwest and I'm pleased to be continuing our work in this area. With our local experience as well as our knowledge in providing multi-site solutions for large organizations we will help them on this journey in the best way possible."

By using this website you agree to accept Medical Device News Magazine Privacy Policy

Exit mobile version