Overcoming 21 CFR compliance challenges – stringent equipment maintenance requirements, overwhelming documentation demands, the need to maintain data integrity. Insights into challenges healthcare organizations face with compliance and how to incorporate new tools and processes for streamlining maintenance processes, reducing compliance burdens, and ensuring the highest standards of safety and efficiency.
The MDIC Annual Public Forum 2024 kicked off this week with experts from the National Evaluation System for health Technology (NEST), the Centers for Medicare and Medicaid Services (CMS), and the FDA. Topics included the future of real-world evidence (RWE) and the integration of AI into the healthcare ecosystem and how can we leverage emerging technologies to bring innovative and safer solutions to patients.
MEDICA 2024 and COMPAMED 2024 trade fairs in Düsseldorf, Germany attract more than 6,000 exhibitors from about 70 countries. These events are globally unique information and business platforms for the entire value chain of medical technology systems and products – including development and manufacturing. MEDICA and COMPAMED will take place from November 11 – 14, 2024.
Automation and digitization of quality processes can improve efficiency, reduce costs, and enhance product quality in manufacturing, allowing for more informed decisions that will contribute to long-term success.
Dave Bailey, VP of Consulting Services at Clearwater Security, highlights the need for top-down support in managing healthcare-related cyber risks and how the new NIST Cybersecurity Framework can help enhance cybersecurity in healthcare and MedTech organizations.
“We’ve arrived at a historically strong rule that will protect the most exposed communities from toxic air pollution while also ensuring that there will be a process that safeguards our nation’s critical supply of sterilized medical equipment.”
Manufacturing jobs can be dangerous, but knowledge is the first step to minimizing the risks associated with these positions. This article discusses five of the most common safety hazards in medical device manufacturing, with tips on how to reduce the risk of employee injuries while maintaining productivity.
Stefano Vicenzetto, Design Systems Engineer at Flex, shares his insights on how Circular Economy principles can be applied within the MedTech industry to reduce environmental impact by shifting away from the linear take, make and waste approach.
The guidance provides a framework that manufacturers can use to show that physics-based or mechanistic computational models used to support regulatory submissions are credible.
The growth of the medical device industry brings increased competition and a need to find ways to become more efficient and cost-competitive, without compromising quality. In this column, Doug Donahue, Director of Foreign Direct Investment and Manufacturing for Guanajuato’s Medical Device Cluster and co-managing partner of Entrada Group, discusses the benefits, challenges and opportunities available for companies investigating Mexico as a manufacturing site.
