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MCRA Publications

Jul — 2022

Compliance Flash: Physician Owned Distributorship

Physician Owned Distributorship

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Jun — 2022

Compliance Flash: Single Use Devices

Re-use of Single Use Devices can put physicians and manufacturers at risk for health care fraud and adulteration.

 

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Jan — 2022

Risk Management is critical to establishing a positive benefit: risk profile and ensuring the best possible patient outcomes. By: Peter Bowness Director, International Regulatory Affairs

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Jun — 2019

MedTech Strategist - Hot Topics in Cardiovascular Devices with Michael John

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May — 2019

The Role of New Technology in Chronic Pain Management

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Mar — 2018

Medical Device Quality: Why Software Is More Challenging Than Hardware

The U.S.
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Feb — 2018

The Impact of U.S. Regulation on Medical Device Innovation

Passion, inspiration, perseverance, altruism, and need have historically been the factors driving innovators.

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May — 2017

Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel

For a company navigating a Class III medical device’s path to market, the U.S.

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Aug — 2016

Four Questions to Help You Avoid Losing a CE Mark

A Clinical Evaluation Report (CER) is part of the process through which a medical device is certified or recertified to carry the CE mark; it appli

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