Rapid advancements in digital diagnostics are revolutionising healthcare, offering unprecedented speed and precision in patient diagnosis. Connected in vitro diagnostic (IVD) devices—integrating cutting-edge sensors, sophisticated software, and seamless cloud connectivity—are at the forefront of this transformation. Yet, as these devices evolve, they face a complex interplay of challenges. Navigating the stringent EU regulatory landscape (IVD Regulation [IVDR], Medical Device Regulation [MDR], and General Data Protection Regulation [GDPR]) while ensuring flawless hardware-software integration and robust cybersecurity creates a delicate balancing act between innovation and patient safety.
As digital diagnostics continue to reshape patient care, the pressing question remains: How do we fully leverage these innovations while ensuring that every breakthrough is secure, reliable, and patient-centric?
Diagnostics and Digital Connectivity
Ery Anguiano has 15 years of medical device experience across a wide array of product types and manufacturers. He earned degrees in Chemical Engineering and Biotechnology from the University of Utah, and worked and consulted on Quality Engineering, Supplier Quality Engineering and Quality and Regulatory Affairs projects for Fortune 500 medical device companies as well as small enterprises. His expertise includes digital products and connected combination devices, such as software-based in vitro diagnostics (IVDs) and smart injectable systems. He has successfully navigated the evolving regulatory landscape for these integrated solutions, ensuring they meet stringent compliance standards. Ery has a deep understanding of US and international quality and regulatory standards, and enjoys guiding small teams to market clearance.