Congenius appoints Dr Sarah Bosshard as new Head of Clinical
We are delighted to announce that Dr Sarah Bosshard has been appointed as our new Head of Clinical. Since joining…
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MedTech news roundup March 2025
Our March MedTech news covers EU-US trade tensions, the Clean Industrial Deal, updated guidance on IVD classification, and calls for…
Congenius
Navigating the regulatory landscape of fast-growing markets | India
India has one of the world’s largest consumer markets. With a large and growing population, rising prevalence of chronic diseases,…
Congenius
Navigating the regulatory landscape of fast-growing markets | Mexico
Mexico’s population is 126 million – and counting. As healthcare becomes increasingly affordable and accessible to the country’s growing population,…
Congenius
Navigating the regulatory landscape of fast-growing markets | Brazil
Brazil stands as a cornerstone of the Latin American healthcare market, but healthcare needs amongst its sizable population are evolving…
Congenius
Chemical Analysis for Biocompatibility Assessment of Medical Devices | Essentials from the FDA draft guidance
In September 2024, the FDA published its draft guidance on “Chemical Analysis for Biocompatibility Assessment of Medical Devices” to improve…
Congenius
MedTech news roundup February 2025
Our February MedTech news covers calls from the European MedTech industry for the EU to become a full member of…
Congenius
Navigating the Ecodesign for Sustainable Products Regulation (ESPR)
The Ecodesign for Sustainable Products Regulation (ESPR) has been effective since 18 July 2024. It represents a groundbreaking transformation in…
Congenius