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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Chemical Analysis for Biocompatibility Assessment of Medical Devices | Essentials from the FDA draft guidance
In September 2024, the FDA published its draft guidance on “Chemical Analysis for Biocompatibility Assessment of Medical Devices” to improve…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
Unpacking the Corporate Sustainability Due Diligence Directive (CSDDD)
The Corporate Sustainability Due Diligence Directive (CSDDD), formally known as Directive (EU) 2024/1760, is a significant milestone in the European…
Congenius
Exploring the Corporate Sustainability Reporting Directive (CSRD)
The Corporate Sustainability Reporting Directive (CSRD) represents a transformative step in sustainability reporting within the European Union. It introduces rigorous…
Congenius
EU Green Deal & Directives 2025
The European Green Deal, adopted in December 2019, is the European Union’s ambitious roadmap to transform Europe into the first…
Congenius
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