Understanding the dimensional stability of injection moulded consumables
Adherence to quality requirements for plastic components in MedTech is becoming increasingly important as MDR and IVDR dictate more stringent…
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Addressing the latest Cybersecurity legislation for medical devices
Many existing medical devices operate on legacy systems, which makes them difficult to maintain and vulnerable to manipulation by hackers.…
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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…
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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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