We are proud to announce that DYCONEX is a founding member of a project being set up by the International Electronics Manufacturing Initiative (iNEMI) entitled «Defining Reliability Requirements for Implantable Medical Devices.»
The proposed focus of the program is to identify the product testing required to ensure the reliability of active implantable medical devices such as pacemakers, defibrillators, cochlear implants and neurostimulators.
The project will be realized in three main phases:
• Phase 1: Review reliability standards relevant to active medical implants
• Phase 2: Analyze gaps and develop protocols
• Phase 3: Recommend applicable methodologies
Dedicated standardization for the testing of such devices will mitigate the risk factors and offer the industry a faster level of innovation and lower litigation risks while delivering reliable products to patients.
For over 15 years, DYCONEX has been a major player in the PCB market for medical implants. Based on that experience, we rate this project to be very significant. Dr. Hans-Peter Klein, Director Quality Management, will therefore join the project from our side. With his profound expertise in business excellence methods, he will be an important asset to this iNEMI initiative.
More information at www.inemi.org
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