Notified bodies receive numerous questions from legal manufacturers during technical assessments. We cannot always answer them for individual legal manufacturers because this would constitute consultation.
We stopped squeezing every last patient slot out of our clinicians. Here’s what happened…
As these regulations continue to change, MedTech companies need to leverage the right systems to streamline processes, ensure continuous compliance, and mitigate the risks associated with non-compliance
When hardware and firmware are developed by separate vendors, diagnosing issues like symptoms of non-performance becomes slower and more complex. Unified engineering teams are essential to MedTech success.
This silent crisis has dire consequences. Patients face delays, errors increase and the entire system suffers. This cannot continue. But in the face of such crippling challenges, how can healthcare practices look to improve the interoperability of their systems?
Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has been a top priority and now, more companies are moving toward EU MDR sustainability. As we look ahead to an unpredictable year in medtech, three areas stand out as opportunities for medtech to drive meaningful progress. AI, recall management, and regulatory intelligence could be key differentiators for medtechs — if approached strategically.
Under IVDR, clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With updated compliance deadlines approaching, how can manufacturers manage risk and avoid regulatory delays and disruptions in their market strategies?
Clear and specific IVD intended use criteria are required and introduce significant challenges for manufacturers seeking CE Marking and global market access. With IVDR compliance deadlines approaching, how can manufacturers manage risk and avoid regulatory delays and disruptions in their market strategies?
With a new executive order to leave the World Health Organization, the Make America Healthy Again (MAHA) movement is driving new policy and promises for faster time to market for product innovation. MedTech start-ups are keen to capitalize on the opportunity, yet funding to push product through early product phases – concept and design through clinical studies and post-market surveillance – can be complex. Daniele Viappiani of GC1 Ventures offers strategies for MedTech start-ups to find the right investors.
Wearables are changing the game for health monitoring. From smartwatches and rings to skin patches, glasses, and even bras, companies are in a race to bring the latest innovations to market. But as this trend gains momentum and competition heats up, so do concerns about potential risks like data privacy, cybersecurity vulnerabilities, and the possibility of inaccurate health readings that could critically impact user safety.