Medical device companies are aiming to optimize their Clinical Evaluation Report (CER) submissions and streamline compliance process. How are RA teams putting together practical strategies for improving efficiency, reducing risk, and staying compliant with MDR regulations?
AI has the ability to revolutionize the medical landscape, but to enable this, Quality Engineering is critically important.
What are the essentials for compliant claims? How do you support and monitor claims in packaging and promotional content? Creating and following internal procedures is a strong defense.
Modern interoperable systems, data centralization, and a wide-angle view of inventory and usage trends are providing hospitals to proactively switch from a “push” to a “pull” supply chain management, allowing for active real-time inventory management and sourcing based on need.
MTI Regulatory Report 2024 data overwhelmingly suggests regulatory resources throughout the industry are being stretched. Time/Bandwidth is the top medical device regulatory challenge faced during 2024, potentially leading to industry-wide regulatory fatigue and driven by changing global compliance regulations in recent years.
The value-based care model, with a substantial monetary budget, necessitates on-time and correct risk stratification. As a result, new and incumbent care providers and payers are reinventing healthcare delivery, looking towards cutting-edge GenAI and machine learning technology to radically transform the healthcare delivery paradigm. This article explores how GenAI and machine learning-based risk stratification are revolutionizing a new era of personalized care, resulting in improved healthcare functions for payers and providers.
As laboratories navigate the evolving landscape of Laboratory Developed Tests (LDTs), the FDA’s phased approach to regulation marks a significant shift. This blog outlines what these new regulations mean for laboratories developing and selling LDTs.
MedTech organizations need to focus on the human factor of change and achieve top-down alignment, buy-in, accountability, and clear communication along the way.
Recently, biocompatibility consultant, MedTech enthusiast and chemist, Marina Daineko, shared a series of LinkedIn posts defining, medical device biocompatibility and the need for a Medical Device biological risk assessment “framework.” Following is a reposting of Marina’s original LinkedIn series.
Fraudulent data is becoming more common by the submission. So much so that the FDA recently published a press release reminding medical device manufacturers to scrutinize Third-Party Generated Data.” Regulatory consultant, Michelle Lott, discusses the agency’s use of artificial intelligence to find unusual patterns in submitted data and how you might guard against using fraudulent 3rd-party data.
