On January 7, 2025, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.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 Recognizing the profound impact of AI, the U.S. Food and Drug Administration (FDA) has issued a draft guidance titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological […]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 […]
Another event that will take place in Split is the Healthtech Adria Conference 2024. Presented by the Croatian healthcare technology development business accelerator NetHub in association with the University of Split School of Medicine, this conference will include interactive demonstrations, lively discussions, and a startup pitch contest. About Healthtech Adria Conference 2024 A vibrant mix […]
Patient-centred design requires a new way of doing things. That means saying goodbye to paper and moving into the 21st century. Integrating information technology (ICT) solutions in healthcare enhances patient care and experience. It increases accessibility to health information and improves patient outcomes. A factor contributing to the success of ICT in healthcare is patient-centered design (PCD). […]
Overview Medical device data integration has become a pivotal element in patient care, introducing an era where healthcare providers and patients can access information in real time. In the past, healthcare professionals depended mostly on in-person appointments to obtain health data. This made it difficult to spot subtle changes in a patient’s condition between visits. […]
Regulatory affairs specialists are leading the charge in clinical research to ensure adherence to the rules and regulations established by regulatory bodies like the Pharmaceuticals and Medical Devices Agency (PMDA), the European Medicines Agency (EMA), the Medicines and Healthcare Products Regulatory Agency (MHRA), and the Food and Drug Administration (FDA). Their proficiency is crucial for […]
