Whether gluing or molding, designers must carefully address each challenge to ensure reliable, consistent, and accurate manufacturing – and to avoid costly redesigns or patient safety risks later.
To navigate increasingly complex global regulations and rising market expectations, organizations are embracing the Intelligent MedTech Lifecycle: a unified, data-driven approach that breaks down silos and drives agility across the entire product journey.
In the healthcare industry where patient lives are at stake, quality culture is a cornerstone principle extending beyond operational efficiency. It has profound effects on patient outcomes. As tech continues to disrupt healthcare, how do technology companies build a robust quality culture to succeed in healthcare?
Public Health Impact of Medical Device Supply Chain Vulnerabilities
The FDA’s Center for Devices and Radiological Health issued a statement on medical device supply chain vulnerabilities, the public health impact they have on patient care, the FDA’s actions to prevent and mitigate potential shortages, and solutions to strengthen the domestic supply chain and address these vulnerabilities.
In a document updated for the first time since 2017, AAMI released new guidance for EO material compatibility and including new alternatives.
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.