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.
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.
Peter Micca of Deloitte discusses the changes that are happening within the healthcare ecosystem as a whole.
Manufacturing microfluidic devices requires sophisticated techniques.
The goal of the voluntary program is to streamline the submission process. The agency also announced that it has selected participants for its EtO Innovation Challenges.
For too long this industry has lagged the pharma sector in terms of using data analytics to predict market trends. It’s time to change that.
Treatment can no longer be one dimensional.