How to develop SaMD | Congenius whitepaper
As health care advances, software has become integrated widely into digital ecosystems that serve both medical and non-medical purposes. To…
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How to achieve successful quality improvement
Many quality improvement projects aim to enhance one or more processes to become more effective, efficient, or compliant – often…
Congenius
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…
Congenius
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…
Congenius
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…
Congenius
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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