When implementing IVDR requirements, it’s important to take a step back and look at the flow of documents.
The agency recently released a guidance document that gives device manufacturers an optional pathway to make certain modifications to their device.
The hot issues are related to compliance, EU MDR and recalls.
Technology will continue to evolve to allow patients greater control over their healthcare.
The idea of harnessing the body’s response to heal and defend is no longer the stuff of science fiction.
With May 26, 2020 quickly approaching, every day counts.
The company developed the device as an alternative to reusable duodenoscopes, enabling the use of a new and sterile product for each procedure.
Medtech companies must account for a more complex web of influencers on purchasing.
Peter Micca of Deloitte discusses the changes that are happening within the healthcare ecosystem as a whole.
Personalized medicine is the future of healthcare, and artificial intelligence will play a big role.