AI-driven regulatory platforms support SaMD organizations by proactively monitoring and adapting to the dynamic global regulatory landscape. The technology alerts users to anticipated regulatory updates worldwide, facilitating improved foresight and trend detection. It also provides guidance on addressing potential lapses in product compliance, integrates with existing workflows and streamlines regulatory tasks from classification to registration and market entry.
For life sciences companies seeking to develop, deploy and successfully commercialize digital health products and solutions, the pathway to success can have many twists, turns and roadblocks. This article examines some of the major challenges to bringing digital health products to market and explores potential opportunities to ease the journey.
Magnetic resonance imaging (MRI) helps discover serious threats early and in a precise and painless way. However, patient safety may be in danger when medical implants interact with the electromagnetic environment. The developers of such implants are obliged to check the safety of their products under these conditions.
Beginning October 1, 2023, the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot will expand to include the Office of Neurological and Physical Medicine Devices (OHT5).
On May 16-17, the MedTech Regulatory Intelligence Summit will bring regulatory affairs professionals and members of the FDA together for two days of education, discussion and networking as we look at challenges and best practices in navigating current and on the horizon regulatory requirements.
Share your research, experience and expertise with your peers at the upcoming Medtech Advanced Manufacturing Conference and Medtech Supply Chain Intelligence Summit. Call for abstracts is now open.
Selecting a strong medical device contract manufacturer is critical to ensure supply chain resiliency, regulatory compliance, and long-term success for a medical device OEM. This article is a guide to the most important questions to ask yourself and your contract manufacturer to help ensure a successful partnership.
The FDA is asking stakeholders to submit public comments on how it should use any portion of the user fee funding that may be distributed to external organizations—other than NEST—to support premarket RWE in medical device evaluation and development.
MedTech Intelligence will host four vertical in-person events in 2023 covering connected care, regulatory compliance, advanced manufacturing and supply chain. The Washington, DC-based conferences bring together MedTech professionals for education, networking and discussion on the key challenges and opportunities facing the MedTech industry.
A mere 13% of IoMT leaders believe their organization is in a good place to mitigate future risks related to cybersecurity.