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Legal, Clinical & Regulatory

Clinical Trials Shift to Hybrid Approaches in the Age of COVID-19 and Beyond

Conducting successful clinical trials will require orthopedic companies to demonstrate flexibility and adaptability in the future.

First 510(k)s for Companies in Joint Replacement, Spine, Trauma, SportsMed and Obio

This month’s recap rounds up many companies new on our radar, helmed by people who've known the industry for a long time. Geographically, they span the U.S., Canada, France and Turkey.   

How to Take a Risk-Based Approach to Biocompatibility

The ISO 10993-1 changes have re-emphasized the need for orthopedic companies to understand and characterize the materials, processes and risks associated with medical devices.