GxP Lifeline Newsletter
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October | 2018
MasterControl GxP Lifeline

Advancing the Case for Quality in Medical Device Manufacturing
by Stephanie Christopher, Program Director, Medical Device Innovation Consortium

 

We look for quality in the products we buy, the teams we are part of, and the service we receive and provide. The question is, how can quality be ensured?

 

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Airplane Preflight Check Exemplifies Quality in Med Device Design
by David Jensen, Staff Writer, MasterControl

 

Any pilot will likely concur that the most important part of a flight is the preflight check. Achieving a safe flight begins with a careful visual inspection of the airplane. Part 1 of this article series introduced BraveHeart and its medical device: the Wearable Life Sensor™.

 

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How Approaching MDR/IVDR Deadlines Are Impacting Med Device Industry
by David Jensen, Staff Writer, MasterControl

 

As the deadlines for Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR) loom, both the medical device industry and the European Commission (EC) are finding themselves in a logistical logjam. Thousands of medical device technologies are currently in use that need to be re-certified under the new regulations by May 2020 for MDR and 2022 for IVDR.

 

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New Digital Pathways Boost Success Rate of Med Device Introductions
by David Jensen, Staff Writer, MasterControl

 

Advances in health care and technology are creating more opportunities for medical device companies to play a larger role as solution providers in the health care value chain. At the same time, the increasing complexity of technology, disruptive companies and a growing trend of medical device and pharmaceutical convergence is making the regulatory environment more challenging and competitive.

 

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