Adhesive selection can make or break the success of a stick-to-skin wearable device. This article reviews six questions to ask the next time you design a device intended for wear on fragile skin.
To change the landscape of cyber threats in healthcare, companies must prioritize designing security into devices.
The government alleges that the company did not disclose serious health events in certain implantable defibrillators.
Automating validation processes gives manufacturers the flexibility and capability to make changes, updates and re-validation, making it easier to upgrade or add new MES modules to their process. Simplifying the process through automation leads to faster ROI and time to market.
Digital twins have the capability to enable safer medical devices and improve overall patient outcomes.
Medical device manufacturers can accelerate their digital transformation priorities through lean practices to better manage supply chain risk, complexity and disruptions.
FDA also supports the removal of the HeartWare HVAD System from the market.
The medtech regulatory environment in Europe has entered a new era. A Europe-wide medical device regulation has come into effect, presenting both challenges and opportunities for stakeholders in the sector.
As the pace of innovation further accelerates in 2021, and the need to get new devices to market intensifies, maintaining adherence to regulatory controls is not enough.
The key is to keep quality high and risk low.