Certifications Archives - NS Medical Devices

DevicesCertificationsDiagnostic Devices

29 Jul 22

The OS Ultra scanners deliver high-resolution images that can be analysed further with the help of OptraSCAN's artificial…

OptraSCAN secures CE-IVDR for OS-Ultra digital pathology system

UK to tighten regulation of medical devices for patient safety

27 Jun 22

The reforms will cover medical devices like hearing aids, x-ray machines and insulin pumps; new technologies such as…

BELKIN Vision’s Eagle receives CE Mark under MDR

17 May 22

BELKIN's sight-saving technology could revolutionize first-line glaucoma care for the more than 100 million people who have glaucoma…

Optellum wins CE mark for AI-based early lung cancer detection tool

DevicesRegulationCertifications

31 Mar 22

The AI-based tool is capable of identifying and tracking at-risk patients with suspicious lung nodules for the detection…

BSI issues first UKCA mark under new medical devices legislation

29 Jan 21

Theatre instrument sets are the first to secure the new UK product marking

How have lockdowns and social distancing impacted the way medical device manufacturers are regulated?

20 Jan 21

Jamie Bell speaks to the BSI's Gary Slack to find out how auditing and other means of medical…

IVDR: What will these new EU regulations mean for in vitro diagnostics manufacturers?

08 Jan 21

In 2022, the long-standing IVDD will be replaced by the IVDR, ushering in a new era regarding how…

RegulationApprovals

Eight key medical devices given emergency use authorisation during Covid-19 pandemic

02 Nov 20

Diagnostic tools, PPE products and patient monitoring systems are among the range of medical devices that have gained…

RegulationApprovals

MedTech Europe issues warning on counterfeit PPE products and fraudulent suppliers

30 Oct 20

In a statement, MedTech Europe said selling counterfeit PPE products, and other fraudulent activities, jeopardise the safety of…