Blogs

When you're responsible for clinical and regulatory strategy, juggling multiple submissions across geographies is more than a challenge—it's a minefield. With the FDA tightening review timelines, CE MDR requirements expanding, CDSCO demanding more localised evidence,...

In the fiercely competitive world of medical device development, speed to market is everything. But for regulatory professionals like myself, it’s a constant tightrope walk between accelerating clinical trials and ensuring bulletproof data integrity. At...

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...