The European Commission’s Green Deal sets specific sustainability targets across the EU, while policies like the German Supply Chain Act (LkSG) of 2023 are setting standards domestically. TÜV SÜD explains how hospital operators and medical device manufacturers can position themselves sustainably in the market.
Harmony™ Transcatheter Pulmonary Valve system received approval for minimally invasive treatment option for patients with congenital heart disease across European Union.
In a document updated for the first time since 2017, AAMI released new guidance for EO material compatibility and including new alternatives.
Computerized Maintenance Management System (CMMS) software can be a vital tool for life sciences manufacturers in maintaining compliance with regulatory requirements.
The United States is currently under the spotlight as Donald Trump’s recent appointment and consequent nomination of Robert F. Kennedy Jr as Department of Health and Human Services secretary are likely to bring a series of crucial changes that will affect the medical device market globally. Manufacturers everywhere are addressing their attention to the US market and waiting for new decisions to be made. In particular, deregulation is on the cards for the sector and the biggest concern is the restructure of the Food and Drug Administration (FDA), as a reduction in regulatory red-tape, though favoring increased competition, could also dangerously shrink examination processes.
Advancements in cardiac care and novel therapies are transforming cardiac medical devices, providing new solutions for millions affected by heart disease globally.
What’s getting R&D attention? The impact of upcoming regulations, A.I., new cybersecurity risks, developments in battery power and innovation, collaborative efforts, and other impacts on the industry in the year ahead.
In the medical device industry, engineering quality is paramount. This is a high-stakes field, and the FDA has zero tolerance for violations. A robust development process not only enhances quality, compliance and efficiency but also boosts profitability.
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.
How will 2025 rise to the challenge of meeting the demand for personalized healthcare? A perspective on the transformative advancements of 2024—highlighting the impact of AI, robotics, and digital health as they begin to reshape the healthcare landscape.
