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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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…
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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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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…
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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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