The deal will increase the company’s suite of cardiac ablation products, including mapping and navigation systems.
A capacitor manufacturing assembly error could cause the device to become inoperable.
Keeping temperature-sensitive medical products within the required levels is vital in today’s world, especially as supply-chain issues are making transportation challenging. Monitoring equipment will ensure items stay safe as they move from the device manufacturer to consumer.
The center is also hoping to move back into more normal review timelines next year.
The agency is encouraging medical device manufacturers to evaluate their risk and take action to remediate any vulnerability.
Enter Killware. As cyberattacks continue to increase in healthcare, medtech companies need to make sure their essential software is up to date. This Q&A with Brian Wrozek of Optiv Security takes a look at how medtech companies and healthcare organizations can address this threat.
As more guidance is released, we can expect to see more agreement between competent authorities and notified bodies. Until this happens, there are still actions you can take to help eliminate the uncertainty.
The shift towards more home-based and distance-care may further change in a post-COVID environment.
Reusable medical devices have many notable advantages. However, they’re not appropriate in all cases. This article discusses some factors designers should consider to make their products as profitable and useful as possible.
EU regulations require manufacturers of medical devices and systems prove the single-fault safety of their products. However, it is not clearly defined in detail how to comply with these requirements. This article explains which technical and legal requirements apply and which aspects should be considered during development.
