If you’re conducting a clinical investigation of a medical device in a European Union member state, you will be required to submit a clinical investigation report (CIR) along with a summary of the CIR to that member state.

In the wake of the Covid-19 pandemic, medical device supply chains are one of the top priorities for health system leaders.

Supply chain management is crucial to any medtech company’s ability to deliver safe, effective, and high-quality devices to their customers.

Getting blood test results can take anywhere from a day to a week, depending on what a test is targeting. The same goes for tests of water pollution and food contamination.

Magnetic resonance imaging (MRI) machines can

In the quickly changing industrial landscape, firms continue to place a high premium on safety. Innovative approaches to improving industrial safety have been made possible by technological advancements.

On Feb. 23, 2022, the U.S. Food and Drug Administration (FDA) released its proposed rule for the new Quality Management System Regulation (QMSR).

Amedical device company is expected to deliver innovative, life-changing devices while ensuring compliance and achieving true quality. This task bears loads of responsibility—all of which must be kept and documented within your quality management system (QMS).

A successful company can’t run without happy and motivated employees. One way you can achieve that is by improving your employees’ uptime.