Analysis

  • Electronic Data Regulation Under Review

    A coalition of FDA-regulated industries is petitioning the FDA. The group wishes to change the existing and proposed regulations on the use of electronic records and signatures.

  • Assembly Technologies for Medical Devices

    Christine Kallmayer and Eric Jung of Fraunhofer IZM look at the flip-chip process and other innovations. All allow the assembly of electronic devices into small, highly reliable packages perfect for...

  • Testing the Future for In Vitro Diagnostics

    Raising awareness of in vitro diagnostics is the key to unlocking their value as tools. They are suitable for identifying and alleviating heathcare problems and reducing the costs associated with...

  • The Modular Route to Optimised Process Control

    A dedicated modular manufacturing execution system can provide higher flexibility and lower risk. It offers solutions to the problem of maintaining high production yields while ensuring strict quality control.

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Driving towards the implementation of the new Medical Devices Regulations (MDR)

  On 5 April 2017, two new Medical Devices Regulations (MDR) on medical devices were adopted, and they entered into…
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