Understanding the nuances is crucial in determining the regulatory submission pathway, data requirements, and even post-approval compliance expectations.
The FDA is aware that Boston Scientific is recalling he Carotid WALLSTENT Monorail Endoprosthesis due to a manufacturing defect that created an inner lumen smaller than specifications, causing resistance when withdrawing the stent delivery system.
The companies have reached a long-term agreement allowing customers to use software, data, technology, and service offerings from Veeva and IQVIA together.
Lumipulse® pTau-217/Beta Amyloid 42 Ratio now available nationwide through Labcorp.
Over the past decade, global regulations for medical technology have skyrocketed from around 500 to over 8000. Navigating the complexities of regulatory compliance is a daunting task—especially when faced with orthogonal aspects of regulations.
The MedTech industry has seen significant growth and raised expectations as it adapts to evolving healthcare needs in the wake of the COVID-19 pandemic. The industry’s ability to make technology a part of everyday life will be key to driving growth and evolving with the demands of a disparate patient population.
As these regulations continue to change, MedTech companies need to leverage the right systems to streamline processes, ensure continuous compliance, and mitigate the risks associated with non-compliance
Press Release: New partnerships mark a significant step forward in expanding the MedTech industry’s adoption of Enlil’s agentic AI-assisted development traceability platform. By aligning with leaders in regulatory consulting and innovation support, Enlil enhances both its service reach and sharpens its ability to deliver end-to-end traceability, faster implementation timelines, and deeper integration across the product development lifecycle.
Many medical device companies want to go to Japan since it is the third-largest market in the world. Oftentimes, device companies want to register their devices quickly in Japan to be on the market and are not focused enough on the initial medical device reimbursement they will get. This can lead to an unprofitable business if the Japanese reimbursement price is not higher than the sales price in Japan. Are there strategies to increase reimbursement?
FDA issued General Correspondence Letters to two third-party testing companies in China after discovering data that was falsified or otherwise found to be invalid.