Leveraging Real-World Evidence in medical device regulatory submissions
Providing data from randomized controlled trials has long been considered the gold standard to demonstrate the safety and efficacy of…
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The EU-Swiss MRA | One year on
Without an updated MRA having been produced by last year’s MDR deadline (26 May 2021), Switzerland became a third country…
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What is Lean Process Validation?
In the medical devices field, the meaning of the term Lean Process Validation can sometimes lack clarity, which can lead…
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How to optimize your supplier management
As the medical device and diagnostics industry continues to grow, supplier management is becoming increasingly multifaceted. The ever-mounting effort required…
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Navigating Clinical Evaluation for SaMD
Clinical evaluation is an ongoing process that’s conducted throughout the life cycle of a medical device. It is a structured,…
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Cybersecurity considerations for Connected Medical Devices
Medical devices are becoming increasingly connected to the internet, hospital networks, and to other medical devices. Whilst this increased connectivity…
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How the early introduction of a QMS will benefit your start-up
The inception of a MedTech start-up stems from someone having a great idea for a new product that improves therapy…
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Clinical Evaluation under MDR: 5 tips for producing compliant CERs
Following a four-year transition period, MDR finally became fully applicable on 26 May 2021. Since this date, clinical evaluations for…
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