With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear—a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.
Last year the agency surpassed a 40-year record set in 2017, approving 106 novel devices.
The agency’s latest announcements are indicative of its focus on risk reduction while promoting innovation.
A great idea is not the same as great execution.
Innovators will also receive guidance in the areas of prototyping, engineering, IP, testing, grant-writing and clinical trial design.
Early-stage companies are seeking cures for diseases from heart conditions to skin cancer.
A look at where tech developments are originating and what to expect.
CDRH is urging the development of medical technologies and diagnostic tests that address pain, addiction and diversion.
For under $500, researchers have developed an open source bioprinter that they say is on par with machines costing significantly more money.
It’s good news for device companies, but industry associations and stakeholders are still seeking a permanent solution.