This month, we're taking you from the lab to the regulatory desk. Get a look inside our Paris cardiovascular lab, then hear from Veranex experts on SaMD, the RAPID pathway, reshoring, women's health, tariffs, and GLP study planning. Plus, discover upcoming training and events to keep you informed and connected.
Advancing Structural Heart Technologies in Paris
Success starts with the right model. For over 20 years, our veterinarian-led team in Paris has designed cardiovascular studies around how species differ from human anatomy, with bypass, imaging, and pathology in one environment. From proof of concept to GLP safety, one expert team supports every stage, advancing products that have treated 1 million+ patients.
Learn more about our cardiovascular expertise and meet our experts in Paris. In-person and remote sessions are available.
Five Questions to Help You Determine If Your Software Is a Medical Device
Understanding where your software falls on the spectrum is typically the first regulatory decision you’ll make for the product.
Planning a Pivotal Trial? Medicare Wants a Say.
The proposed RAPID pathway builds CMS coverage outcomes into IDE studies for Breakthrough Devices. Here's what it means for your trial design.
Reshoring a Medical Device? Make the Move Count Twice.
If your medical device is showing its age or if complaints, cost pressure, supplier obsolescence, or a competitor closing in are forcing the issue, the reshoring window is the right time to address Gen 2.
It's Not What You Think: Evaluating Your Right to Play in Women's Health
Decades of male-centric data hide real risk in women's health. Learn the red flags and what market readiness looks like.
Tariff-Proof Your Device, Starting With Materials
Early material and component choices decide whether tariffs and supplier changes become setbacks or non-events.
Two Hours on Surgery. Fifteen Minutes on Pathology.
Imbalances in study planning are behind three costly GLP failures, and each one is preventable.
