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Articles Tagged "EU MDR"

ISO 14971 Update Recognized by FDA, Aligned with EU MDR on Risk Management

by Heather Tunstall | Jan 2020

The medical device risk management standard was updated to better align with changes in medical device regulations around the world. The standard emphasizes postmarket surveillance, is recognized by FDA and aligns with EU MDR requirements. ... Read more »

Supply Chain Quality Panel, Part I: OEM and Supplier Perspectives

by BONEZONE | Jun 2018

In this installment, supply chain experts from Autocam Medical, MicroPort Orthopedics, Orchid Orthopedic Solutions and Zimmer Biomet discuss customer differentiation, building partnerships, regulatory challenges and continuous improvement efforts. ... Read more »

Value Analysis Committees, EU’s MDR Highlighted in OMTEC Surgeon Keynote

by BONEZONE | Apr 2017

Increased regulatory scrutiny and payor power continue to affect healthcare globally, leading companies to create cross-department teams and seek collaboration amongst customers within the supply chain in order to remain innovative and competitive.... Read more »