Digital vehicle reimbursement solutions not only ensure fair compensation for employees, but also aid companies in managing costs.
“Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development.
“We’ve arrived at a historically strong rule that will protect the most exposed communities from toxic air pollution while also ensuring that there will be a process that safeguards our nation’s critical supply of sterilized medical equipment.”
Post-market surveillance plays a critical role in the UK’s medical device regulatory framework. Manufacturers must prioritize establishing a comprehensive PMS system, developing clear and organized PMS plans, and promptly reporting incidents and corrective actions.
Medtech stakeholders can now search for MedAccred accredited suppliers. Accredited companies included in the QML have achieved MedAccred Accreditation after meeting stringent critical process audit requirements set by MedAccred OEM Subscribers, which include Baxter, BD, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips, Roche Diagnostics, and Stryker.
Medical Electronic Products of the future will be largely free from wires and cables, aside from a power source. “Wireless medical devices” offer numerous advantages. However, they are also subject to extensive legal regulations governing aspects such as the radio technology used in them. In addition, they may have to be assessed by a Notified Body such as TÜV SÜD.
Ashwini Sharan, M.D., Chief Medical Officer of the Neuromodulation Division at Medtronic, discusses the development of the company’s recently CE Marked Inceptiv closed-loop spinal cord stimulator system for chronic pain and how the company plans to further incorporate closed loop technologies in its neuromodulation pipeline.
The National Institute of Standards and Technology (NIST) has updated its Cybersecurity Framework (CSF) guidance document for reducing cybersecurity risk. The new 2.0 edition is designed for all audiences, industry sectors and organization types. This is the framework’s first major update since its creation in 2014.
How to choose the right sterilization method for silicone-based medical devices and a look at novel silicone technologies.
Following a “alarming” increase in medical device submissions containing unreliable data, the FDA is reminding manufacturers and study sponsors that they are responsible for qualifying third-party test labs and closely scrutinizing all testing data.
