You searched for Mark I. Froimson, M.D., MBA

Why You Should Stop Saying “Volume to Value” in Healthcare

"Our goal should continue to be to improve outcomes and experience for the greatest number of patients possible by providing them with the types of care and experiences that they want and would pay for," says Mark Froimson, M.D., MBA.

Feb 19 2018, Mark I. Froimson, M.D., MBA

Regulations

The Basics: Understanding the Medical Device Single Audit Program

MDSAP was launched to leverage resources of regulatory bodies in the U.S., Canada, Brazil and Australia to monitor device manufacturers. Here is a breakdown of how the pilot program works and each country’s participation.

Feb 10 2015, Robert Packard

Regulations

MDR Experts Share How to Successfully Navigate the Requirements

Notified Body representatives and regulatory consultants provided an update on MDR compliance at OSMA's summer meeting. We review the advice around significant change, legacy devices, economic suppliers and more.

Oct 30 2020, Sharon Starowicz

Market Forces

Surgeons Seek Innovation in Instruments, Delivery of Care

OMTEC’s Closing Panel brought together surgeon executives and entrepreneurs with diverse market backgrounds–joint reconstruction, spine and trauma–to provide perspective on patient-specific instruments, single-use devices, ASCs and more.

Jul 18 2018, Carolyn LaWell

Regulations

EU MDR: How to Respond to Today’s Knowns and Unknowns

Orthopedic device companies implementing EU MDR should consider these eight actions, while thinking strategically about the unknowns of the regulation.

Apr 19 2019, Carolyn LaWell

Regulations

Your EU Medical Device Regulation Guide

Big changes are underway for the European market and how it regulates medical devices with the recent unveiling of the Medical Device Regulation MDR 2017/745.

Oct 09 2017, Deborah Munro

Regulations

Medical Device Single Audit Program Attracts Growing Interest from U.S. Companies

While device manufacturers were slow to adopt the program in its pilot days, the initiative has gained traction since FDA named it an official program earlier in 2017.

Dec 04 2017, John Gagliardi

Regulations

MedTech is Unprepared for MDR Deadlines, Survey Highlights

MedTech Europe concluded there's an urgent need for immediate action to help keep needed medical devices available in Europe.

Jul 22 2022, Kaitlyn McGarvey

Regulations

EU Proposes Significant Changes for Importers and Distributors

The EU’s proposed Medical Device Regulation will subject companies within the supply chain to the same rules, which differs from the current fragmented national regulation.

Dec 10 2014, Erik Vollebregt and Arber Gjunkshi

Regulations

Regulatory Experts: ‘Stay the Course’ When it Comes to MDR Strategy

The European Commission is providing more time to certify devices, but orthopedic companies should proceed with their transition efforts.

Feb 06 2023, Carolyn LaWell

Get the BONEZONE newsletter!

CONTACT BONEZONE

CONTACT BONEZONE