Tag: eDHR

Medical Devices

Waiting for an eDHR Mandate? Best-in-Class Medical Device Manufacturers are Already There

In today’s highly competitive, fast-paced medical and diagnostic device industry, manufacturer’s often struggle to find the right time to shift away from their costly, inefficient and error-prone processes, such as assembling a DHR (Device History Record) from multiple paper and spreadsheet sources.

Medical Devices

A Better Approach to Maintaining Device History Records for FDA Compliance

Current FDA regulations encourage medical device companies to use the latest collection technologies and improve their delivery systems.

Medical Devices

5 Ways Manufacturing Execution Systems Will Accelerate Quality in Medical Devices in 2016

Quality must become the catalyst that unifies the diverse departments of any organization if it is going to strive.

Medical Devices

Tackling Medical Device CAPA Deficiencies

A Corrective Action System is an effective and essential tool, but it needs to be efficient to be truly effective.

Medical Devices

Uncover Hidden Medical Device Cost of Quality Issues with MOM

MOM systems oversee all the stages of production from the acquisition from your suppliers of raw materials to the completion of the finished product.

Overall Equipment Effectiveness

5 Killers of Cycle Time

Sure, you have a lean shop and your personnel can quickly access their tools, but after that shop is lean and they are still spending time not working on product, then you are suffering from one of the top five killers of cycle time.

Medical Devices

What is an Electronic Device Record?

The term eDHR - electronic device history record - is being thrown around a lot these days. But what exactly is an eDHR?