The regulatory landscape for medical devices is rapidly evolving, catapulted most recently by European Union Medical Device Regulations (EU MDR). In this article, Monali Bhansali, Practice Lead of Regulatory Affairs at Tata Elxsi, highlights challenges and advancements in the MedTech regulatory landscape, and what the future has in store.
An adhesive developer explains why skin is so challenging to adhere to, why it’s never too early to explore skin-adhesive options for your wearable device, and recent milestones in stick-to-skin adhesive longevity.
Regulatory requirements for computer systems validation (CSV) have long been in place, but their compliance requires considerable time and resources. In the life sciences industry, traditional validation processes add to project timelines and costs, affecting time to market and preventing the deployment of newer versions of software. In addition to improving accuracy and coverage, automated CSV processes can create the same artifacts as manual execution and expedite the upgrade timeline.
Connected devices already enable remote patient monitoring by collecting real-time data, such as injection date and time. With time, these benefits are likely to grow. Following are three areas where manufacturers are exploring new uses of digitalization in drug delivery to better understand the needs of patients and healthcare professionals and create more effective devices.
On May 16-17, the MedTech Regulatory Intelligence Summit will bring regulatory affairs professionals and members of the FDA together for two days of education, discussion and networking as we look at challenges and best practices in navigating current and on the horizon regulatory requirements.
Internet-enabled medical technologies have significantly improved the standard of care. They have also introduced a range of challenges for healthcare practitioners, administrators, and patients. The good news is these issues can be mitigated—or, in some cases, eliminated—in the engineering and design phase. Following are five key considerations for manufacturers to help foster connected healthcare’s continued acceleration.
IVDR has significant implications for the manufacturing of IVD devices, as it requires manufacturers to comply with new and more rigorous regulatory requirements. Wiktoria Banczyk, Product Manager Lab Filtration Medical Devices at Sartorius Lab Instruments, discusses the challenges posed by the implementation of EU IVDR 2017/746 and key considerations for manufacturers as they navigate today’s regulatory landscape.
MedTech is evolving from siloed products and devices to increasingly multi-functional and integrated digital systems, and device manufacturers are faced with significant challenges in bringing these connected solutions to market. Slow and expensive development lifecycles, complex and inflexible device architectures, and the need for increased cybersecurity, are among the key challenges. The solution lies in a new generation of devices powered by intelligent software data flow.
Only one third of “The State of ESG in Manufacturing” survey respondents have high confidence in the quality and accuracy of their supply chain data. This article summarizes the risks of poor data, the seven elements that contribute to siloed data, and the associated regulatory risks.
On May 16-17, device developers, regulatory affairs and regulatory intelligence professionals will come together in Washington, DC, for two days of education, discussion and networking to share strategies and best practices on navigating current and on the horizon regulatory requirements.
