Human Centred Design Expert Group
For several years now, Medical Cluster has coordinated specialist groups. Raimund Erdmann, the initiator of...
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US FDA Quality System Regulation Vs ISO 13485:2016
This white paper features an alignment chart that can be used to clarify the corresponding...
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Safeguarding the Integrity of Medications: Shipping Matters
The US Food and Drug Administration (FDA) approves medications only after vigorous clinical trials demonstrate...
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Medical Device Labeling – Regulations in the US, EU and China
Medical technology has advanced to a point where people are able to live longer lives...
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Ginolis: Precise Quality by Innovative Automation
Ginolis' vision is to provide more effective healthcare for the benefit of patients globally by...
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Are You Ready for US Medical Device Reporting Code Transition?
This white paper outlines the current coding requirements for reporting adverse medical device events to...
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What is Micro-Molding?
There seems to be a lot of talk these days about micro-molding. This reflects the...
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Responding to Deficiencies During FDA Premarket Submission Review
The majority of medical device companies that submit Food and Drug Administration (FDA) submissions, including...
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Medical Power Solutions
This white paper showcases Traco Power's power solutions for medical equipment.
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Assuring Component Reliability in Medical Electronic Devices
While reliability is critical for electronic medical devices, its just as crucial for the components...
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