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How to achieve successful quality improvement

19/05/2022

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

06/05/2022

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

21/04/2022

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?

07/04/2022

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

24/03/2022

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

17/03/2022

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

09/03/2022

Medical devices are becoming increasingly connected to the internet, hospital networks, and to other medical devices. Whilst this increased connectivity…

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How the early introduction of a QMS will benefit your start-up

17/02/2022

The inception of a MedTech start-up stems from someone having a great idea for a new product that improves therapy…

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Topical Article

How to achieve successful quality improvement

Leveraging Real-World Evidence in medical device regulatory submissions

The EU-Swiss MRA | One year on

What is Lean Process Validation?

How to optimize your supplier management

Navigating Clinical Evaluation for SaMD

Cybersecurity considerations for Connected Medical Devices

How the early introduction of a QMS will benefit your start-up

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Topical Article

How to achieve successful quality improvement

Leveraging Real-World Evidence in medical device regulatory submissions

The EU-Swiss MRA | One year on

What is Lean Process Validation?

How to optimize your supplier management

Navigating Clinical Evaluation for SaMD

Cybersecurity considerations for Connected Medical Devices

How the early introduction of a QMS will benefit your start-up

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