Cyberattacks are increasingly common in the health care industry. As the number of networked medical devices increases, so does the urgency for makers of these devices to understand and mitigate threats to device security. In an increasingly interconnected and digital...
Expertise: Medical Device 45 results
The upcoming compliance deadlines for the European Union Medical Device Regulation (EU MDR) have dominated conversations about the increasingly complex regulatory landscape device manufacturers are facing. But it’s important for device manufacturers to remember that regulations are shifting elsewhere in...
The changes are significant. Here’s what you must know. The EU Medical Device Regulation sets the stage for an arena where transparency, quality, and patient safety are paramount. Manufacturers must prepare and build compliance into their product development strategy to...
The EU Medical Devices Regulation (MDR) was published on May 5, 2017. The impetus behind these new, more rigorous regulations was in part to reflect the substantial technological and scientific advances made by the medical device sector and in part...
Connected medical devices, like all other computer systems, are vulnerable to threats that may lead to compromise of data confidentiality, integrity, and availability. To address these challenges, the Healthcare and Public Health Sector Coordinating Council (HSCC) Joint Cybersecurity Working Group...
Medical Device
Planning for Quality in Medical Device Clinical Trials
Risk-based monitoring is a comprehensive approach to clinical trial monitoring that focuses on proactively identifying and addressing risks to patient safety and data quality. Effectively navigating the shift from traditional on-site monitoring to risk-based monitoring requires cross-functional collaboration and careful...
Compliance with the EU Medical Devices Regulation (MDR) is a significant undertaking that requires cross-functional collaboration. In this post, we explore key activities involved in strategic planning for compliance. Establishing a leadership team Good leadership is essential for managing the...
With the looming deadline for compliance with the EU Medical Devices Regulation (MDR), device manufacturers face a host of questions about how to prepare their existing products for compliance. In this post, we provide answers to top questions about EU...
As medical device regulations evolve and global, multi-center studies become increasingly common, a growing number of sponsors are turning to independent committees such as Data Monitoring Committees (DMCs) or Clinical Endpoint Committees (CECs) for assistance with clinical trial oversight. However,...
Medical Device
Demystifying the Differences Between DMCs and CECs
In a clinical trial landscape where global, multi-center studies have become increasingly common, trial monitoring has become more complex. Regulations require that sponsors of medical device studies perform site monitoring to ensure that investigators are compliant with federal regulations, sponsor...