Blogs

In the medical device world, innovation gets the headlines—but compliance makes or breaks your business. And when compliance fails, the consequences go far beyond fines. For regulatory leaders like me, compliance isn’t a box to...

If you’ve ever had to rewrite a regulatory submission, respond to endless queries from a notified body, or watched a market launch get delayed over a minor documentation issue—you know this truth: Regulatory success isn’t...

As someone leading clinical operations and regulatory strategy, I’m always hunting for ways to run faster, smarter trials—without risking compliance or data integrity. That’s why decentralised clinical trials (DCTs) have captured my attention. And frankly,...