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On October 23, the European Parliament adopted a resolution revising specific elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). This resolution intends to address ongoing challenges in implementing the regulations by 2025 and to improve patient access to important medical products.
Exploring the evolution from wellness apps to regulated medical devices, highlighting the significance of global compliance and security.
Addressing product development and regulatory hurdles, medical device and IVD manufacturers are advised to assess capabilities and seek external expertise for market success.
An overview of essential human factors engineering standards and guidance for global medical device manufacturers.
Navigating the complexities of medical device recalls requires a robust management plan and clear communication strategies.
A guide to regulatory clearances, global reimbursement strategies, and the essential PICO approach.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
