Posts Tagged ‘medicaldeviceregulations’

Getting QMSR Ready: Key Changes and Steps to Prepare for the February 2026 Deadline

Prepare Your Quality Management System for QMSR Compliance by February 2026

With the February 2, 2026 compliance deadline for the new Quality Management System Regulation (QMSR) approaching, medical device manufacturers should start planning now for this significant regulatory shift. This updated regulation will replace the current Quality System Regulation (QSR) and align with ISO 13485:2016, marking a notable evolution in quality management practices for medical device production. Read more »

Your Guide to the 2024 Combination Products Summit: Agenda, Insights, and What to Anticipate

Agenda and Expectations for the 2024 Combination Products Summit: Navigating the Future of Healthcare

The healthcare landscape is constantly evolving, and with it, the need for innovative solutions in combination products—those unique blends of drugs, devices, and biologics that present distinct challenges for development and commercialization. The 2024 Combination Products Summit is the premier event where industry leaders, regulators, and experts come together to tackle these challenges head-on.

This year’s summit promises to be more impactful than ever, offering a comprehensive agenda that will equip professionals with the knowledge and tools they need to navigate the complexities of combination products in a dynamic regulatory environment.

Read more »