Medical Innovation Exchange

EU MDR

Veranex Acquires Medidee

Veranex Acquires Medidee     Veranex, a global, tech-enabled service provider dedicated to the medical technology industry, has acquired MedTech consultancy Medidee, headquartered in Lausanne, Switzerland. The acquisition will expand and strengthen Veranex’s regulatory affairs, clinical development and quality assurance services for medtech companies, including an improved ability to navigate EU-MDR/IVDR challenges thanks to Medidee’s experience …

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Device Labeling: Best Practices

Device Labeling: Best Practices     EU MDR required companies to make significant changes to their medical device labels, highlighting the need for a well-coordinated and agile device labeling process. We spoke with Laura Johnson, director of sales with Loftware, an enterprise labeling and artwork management provider, to discuss common pain points in label development and …

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The Same, But Not Identical: Demonstrating Biological Equivalence Under MDR

The Same, But Not Identical: Demonstrating Biological Equivalence Under MDR     Equivalence strategies can be used to efficiently demonstrate the safety of a medical device, limiting the need for new studies and testing. Given the level of investment that may be needed to achieve compliance with the EU Medical Device Regulation (MDR), leveraging equivalence may …

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State-of-the-Art: Unpacking MDR’s Evolving Requirements

State-of-the-Art: Unpacking MDR’s Evolving Requirements     The Oxford Dictionary defines “state-of-the-art” as something that belongs or relates to the most recent stage of technological development. It is something that incorporates the newest technology, ideas and features. In short, state-of-the-art means the most advanced, sophisticated, innovative version of a thing. The European Union’s Medical Device Regulation …

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