The Regulatory Tsunami: Why Medical Device Industry Need to Prepare for 2025 & Beyond – A Perspective from the Trenches

The Regulatory Tsunami: Why Medical Device Industry Need to Prepare for 2025 & Beyond – A Perspective from the Trenches

2025 is a critical inflection point. This isn't just another regulatory hurdle; it's a fundamental shift that will redefine the landscape. Those who cling to outdated strategies risk not just falling behind, but being swept away entirely.

My career, spanning from Industrial Microbiologist to leading RAQA for India subsidiaries, has given me a front-row seat to the increasing complexity of medical device regulation. From navigating emerging regulatory situations to leading global teams to meet compliance, I've seen firsthand the challenges industry face.

Several converging factors are creating this regulatory storm, & highlighted their growing impact below:

🔹Increased Scrutiny & Enforcement: Increased rigor of audits & heightened focus on PMS. Compliance Bar is constantly rising, demanding meticulous documentation & proactive risk management.

🔹Global Harmonization Efforts: Initiatives like MDSAP are forcing to adopt a global mindset, demanding robust QMS 

🔹Focus on SaMD & AI: Need for clear guidelines on categorization, risk-based classification, validation, is more urgent than ever.

🔹Emphasis on Cybersecurity & Data Privacy: Increasing sophistication of cyber threats demands robust security measures & compliance with evolving data protection regulations.

🔹Supply Chain Disruptions & Increased Complexity: Ensuring quality and compliance across increasingly complex global networks is a major challenge. To know more click here.