Congenius Whitepaper | Overcoming the challenges of regulating combination products
Combination products have existed in both the EU and the US markets for several decades, but regulations for combination products…
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EUDAMED roundup | What’s happened and what’s next
The creation of a European database for registering certified medical devices is regarded as a cornerstone of the EU MDR…
Congenius
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…
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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…
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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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