Aging, an inevitable biological process, has long been associated with a decline in physiological functions and an increased risk of chronic diseases. However, recent advancements in aging research and drug discovery are challenging this narrative, offering promising avenues to not only extend lifespan but, more importantly, healthspan—the period of life spent in good health. This […]
Healthcare technology has advanced by leaps and bounds, yet one timeless challenge remains: patients won’t benefit from innovations they don’t use. Even the most effective medical device or digital health app can fall short if patients aren’t engaged or motivated to use it consistently. Behavior change design is emerging as the key to bridging this […]
I have always believed that the real power of business lies in sustainable growth. This conviction has guided me through every partnership, project, and strategic decision I have made. As the CEO of Aura Health, a company that collaborates with pharmaceutical and life sciences organizations to develop and commercialize digital health solutions, I am keenly […]
Saray Ugidos Seman, Head of Clinical, Regulatory, and Quality Affairs at Aura Health, highlights the critical role of regulatory expertise in the early stages of medical device development. She underscores that startups, in particular, must prioritize regulatory knowledge to avoid costly setbacks and ensure a smoother path to market entry. Many emerging companies underestimate the […]
On January 7, 2025, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations. This document consolidates and refines the agency’s existing recommendations for the content required in marketing applications for medical devices that incorporate AI-driven software functions. The goal is to […]
Artificial intelligence (AI) is rapidly transforming the landscape of drug development, offering innovative solutions to complex challenges in the pharmaceutical industry. Recognizing the profound impact of AI, the U.S. Food and Drug Administration (FDA) has issued a draft guidance titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological […]
Achieving ISO 13485 certification is a critical step for organizations in the medical device industry to demonstrate their commitment to quality and regulatory compliance. ISO 13485 is the internationally recognized standard for quality management systems (QMS) specific to medical devices. Certification ensures organizations consistently meet customer and regulatory requirements, improving processes and market reputation Our […]
The MedTech sector has traditionally relied on hardware solutions to meet healthcare demands. From diagnostic tools to implantable devices, hardware has been at the core of innovation. But the landscape is changing. As healthcare becomes more connected and technology-driven, digital transformation is no longer a buzzword—it’s a necessity. For MedTech companies, the shift to digital […]
Clinical investigations are crucial in the process of bringing a medical device to market. Although they are often seen as challenging and complex, having a solid understanding of the relevant standards can simplify the experience. Familiarity with ISO 14155:2020 is vital, as it serves as a guide for Good Clinical Practice (GCP) in clinical investigations […]
Introduction to EU MDR The European Medical Device Regulation (EU-MDR) 2017/745 took effect on May 26, 2021. It replaced the Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). This newer framework introduces more demanding requirements to bolster product safety, performance, and post-market tracking. Medical device manufacturers must create an EU MDR […]
