News | Flat Panel Displays | November 04, 2019

Detection Technology Awarded ISO 13485-2016 Certification for Medical Flat Panel Detectors

The certification from the TÜV SÜD Product Service GmbH certification body covers the development, production and distribution of X-ray flat panel detectors.

 Detection Technology X Panel

Kai Utela, VP Operations, said Detection Technology is proud to have a certified Medical Device Quality Management System (MDQMS) that will ensure the quality of its newly launched X-Panel product family, shown here.

November 4, 2019 – Detection Technology, a global leader in X-ray detector solutions, has been awarded the ISO 13485:2016 certificate from the TÜV SÜD Product Service GmbH certification body. The certification covers the development, production and distribution of X-ray flat panel detectors.

“We are proud to have a certified Medical Device Quality Management System (MDQMS) that will support us to ensure the quality of our newly launched X-Panel product family. The implementation of ISO 13485:2016 is internationally one of the most valued models for demonstrating compliance with the customer and the applicable regulatory requirements of the medical industry,” said Kai Utela, VP Operations at Detection Technology.

“The certification represents an important milestone for our company and our commitment to deliver solutions for stringent applications with a quality-first attitude. With the certified MDQMS, our customers can be confident that our CMOS X-ray flat panel detector solutions will enhance safety and the patient experience, and that we are meeting their efficiency and responsiveness expectations. Furthermore, we can easily widen the scope of the certification to also cover our other existing and future medical product portfolios, if it is seen to benefit both our customers and our business.”

The company’s Medical Device Quality Management System was audited in September, and the ISO 13485:2016 certification was granted to its Beijing manufacturing site in October. The new certification complements the company’s existing ISO 9001:2015 and ISO 14001:2015 certifications.

For more information: www.deetee.com

 

Related Content

The study finds it's possible to use commercial facial recognition software to identify people from brain MRI that includes imagery of the face
News | Magnetic Resonance Imaging (MRI) | November 15, 2019
November 15, 2019 — Though identifying data typically are removed from medical image files before they are shared for
Image by Pexels from Pixabay RSNA 2019

Image by Pexels from Pixabay 

News | RSNA | November 15, 2019
November 15, 2019 – The 105th Scientific Assembly and Annual Meeting of the...
62-year-old woman with pure ground-glass nodules (GGN). PET/CT fusion image shows pure GGN with tumor maximum standardized uptake value of 2.8 (circle).

62-year-old woman with pure ground-glass nodules (GGN). PET/CT fusion image shows pure GGN with tumor maximum standardized uptake value of 2.8 (circle).

News | PET-CT | November 15, 2019
November 15, 2019 — According to an article published ahead-of-print in the...

Guerbet presented its Contrast&Care injection management solution at ECR 2018

News | Contrast Media | November 13, 2019
November 13, 2019 – Guerbet, a global specialist in...
Mindray announced its partnership with Cincinnati Children's Hospital Medical Center, one of the top children's hospitals in the United States
News | Ultrasound Imaging | November 13, 2019
November 13, 2019 – Mindray announced its partnership with...
 MaxQ AI
News | Artificial Intelligence | November 13, 2019
November 13, 2019 – MaxQ AI announced a new partnership agreement with...
An image on Brigham and Women's Hospital's 7T MRI system

An image on Brigham and Women's Hospital's 7T MRI system. Image courtesy of Brigham and Women's Hospital

News | Magnetic Resonance Imaging (MRI) | November 13, 2019
November 13, 2019 — Increased immune system activity along the surface of the brain, or meningeal inflammation, may b
The ALS produces various wavelengths of bright light that can be used to explore the microscopic chemistry, structure, and other properties of samples

Two researchers from Cairo University in Egypt brought 32 bone samples and two soil samples to study using X-ray and infrared light-based techniques at Berkeley Lab's Advanced Light Source (ALS). The ALS produces various wavelengths of bright light that can be used to explore the microscopic chemistry, structure, and other properties of samples. Image courtesy of Marilyn Sargent/Berkeley Lab

News | Radiology Imaging | November 13, 2019
November 13, 2019 — Experiments at the Department of Energy's Lawrence Berkeley National Laboratory (...
 Paxera Ultima 360
News | Enterprise Imaging | November 12, 2019
November 12, 2019 — Medical Imaging developer PaxeraHealth will showcase the