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Articles Tagged "EU MDR"

EU Allows Notified Bodies to Conduct Audits Remotely

by BONEZONE | Jan 2021

While remote auditing will be conducted on a case-by-case basis, Notified Bodies and members of industry expect the shift could ease the backlog created by MDR and COVID.   ... Read more »

EU MDR Postponement Clears Another Hurdle

by Carolyn LaWell | Apr 2020

The European Parliament voted to postpone MDR until 2021. The regulation's postponement now moves to its final steps. ... Read more »

MDR Deadline Still On—for Now

by BONEZONE | Mar 2020

The European Commission will propose delaying the MDR deadline by one year. The announcement came after MedTech Europe and others called on the commission to pause the regulation, noting that device companies’ response to COVID-19 disrupts their ability to meet the transition timeline date.  ... Read more »

How to Approach Risk Management Under ISO and MDR Updates

by BONEZONE | Mar 2020

Question: How do I handle medical device risk management and the change from ALARP to AFAP? Virginia Anastassova of StarFish Medical advises that staying current with the latest regulations, standards and guidance is key.   ... Read more »

This is What it Takes to be Competitive in Today's Medical Device Market

by Heather Tunstall | Feb 2020

Findings from a new survey of 524 medical device professionals can help you benchmark yourself against best-in-class companies in the areas of product and quality management.... Read more »

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 »