
From Reactive to Ready: The Role of Standards Tracking in MedTech Compliance
Proactive standards tracking helps MedTech companies stay audit-ready and globally compliant
Proactive standards tracking helps MedTech companies stay audit-ready and globally compliant
On June 17, 2025, the European Commission released a significant update to MDCG 2019-11, the foundational guidance on the Qualification and Classification of Software under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).
The UK’s MHRA has issued a substantial update to its Manufacturer’s Online Reporting Environment (MORE) portal, in preparation for the Post-Market Surveillance (PMS) regulatory changes that will take effect across Great Britain on June 16, 2025.
Regulatory intelligence refers to the continuous process of gathering, analyzing, and applying regulatory information to support compliance, accelerate approvals, and guide market entry.
This article provides a detailed overview of the M11 draft which covers how clinical trial protocols are created, shared, and reviewed.
Artificial Intelligence (AI) is no longer emerging in healthcare, it’s here and it’s changing everything. From revolutionizing diagnostics to enabling real-time patient monitoring, AI is accelerating innovation across the MedTech landscape.