When medical device companies make an application or submission to the Food and Drug Administration (FDA) a lot of thought goes into how to present the best case. However, it’s easy to get so caught up in the big picture of the device that smaller...

With active substance renewals generally happening every ten years in the EU, the regulatory landscape can shift significantly between renewals or after initial approval. For instance, compounds coming up for renewal under the EU’s AIR-4, AIR-5 or...

As any medical device manufacturer knows, obtaining 510(k) clearance can represent a significant milestone in the product development journey. It can also be perceived as a major hurdle. This article looks at key elements of the process and how to...