*Photo credit from HealthTEC.SG

Dealing with regulatory certifications can feel like trying to solve a puzzle with missing pieces. Founders often find themselves stuck, unsure of which certification to pursue, when to start, or whether to handle it themselves or hire consultants. To tackle these challenges, we teamed up with Healthtec.SG to host a lively session with medtech/digital health founder Rex Tan (Aevice Health) and regulatory experts, Wing Gang Seet (Cook Medical) and May Ng (ARQon) to share invaluable insights tips on Quality Management System (QMS) and global regulatory strategies with our audience of local and foreign startups.

Though the encountered stories shared about these areas are often frustrating and confusing, they form the backbone of all medtech startups.

Rex’s top advice? Don’t be scared of the regulators! Instead, embrace them. Request feedback or arrange pre-submission meetings. These steps can help you get clear guidance, design the appropriate clinical trial and make your document submissions much smoother.