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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
MedTech news roundup April 2022
This month’s roundup includes an update on the EU Commission’s joint implementation plan for IVDR, guidance from the MDCG on…
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
MedTech news roundup March 2022
This month’s roundup covers tackling medical device supply shortages in Switzerland, advice on direct procurement of foreign medical devices into…
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…
Congenius
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,…
Congenius
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…
Congenius
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