LNE-GMED UK has been designated as a UK Approved Body to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. Scarlet NB UK has been designated with a focus on assessing and certifying software and AI as a medical device (AI/SaMD).
Orthogonal worked with Brian Binkowski, to gain a clearer picture of the state of SaMD approvals in the U.S. Following is what they learned about the rate of FDA approvals and clearances and which companies are having the most success getting their products cleared for the U.S. market.
The 25th session of the International Medical Device Regulators Forum will be held March 11-15 in Washington, DC. The free event is open to the public and includes both in-person and virtual attendance options, Registration deadline is February 16.
Device manufacturers and importers will have two years to modify their Quality Systems to meet the requirements of the QMSR rule by February 2, 2026.
As part of its reorganization of the CDRH, the FDA has elevated the Office of Strategic Partnerships and Technology Innovation (OST) to a Super Office that will include the Office of Supply Chain Resilience (OSCR), Digital Health Center of Excellence (DHCoE), Office of Technology and Data Services (OTDS), Office of Readiness and Response (ORR) and Office of Equity and Innovative Development (OEID).
The Digital Medicine Society (DiMe) is partnering with PHTI, ZS, and other leading organizations to develop and launch core components of integrated evidence plans for digital health products to support faster regulatory approval and commercialization.
Emerging technologies, integrated vendor ecosystems and enhanced regulatory compliance will redefine care delivery and shape the needs of healthcare stakeholders. Following are six healthcare technology trends that will shape care delivery and the MedTech market in 2024.
Ensuring the safety and efficacy of healthcare products is of utmost importance. The clinical evaluation process of medical devices is vital for demonstrating the device’s safety and performance in accordance with the regulatory requirements. How are device makers navigating this complex process effectively.
If adopted, companies would have additional time—from 2027 to 2029, depending on the type of device—to gain approval under EU IVDR.
“FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO),” the second in a series of medical device sterilization town hall discussions hosted by the FDA, will take place on January 26 from 12:00pm – 1:00pm ET.
