GxP Lifeline Newsletter
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July | 2018
MasterControl GxP Lifeline

Top 5 Medical Device Industry Trends in 2018: Atypical Medical Device Technology Will Become More Typical
by David Jensen, Staff Writer, MasterControl


The influx of technology companies outside of the health care sector developing medical treatment products has been going on for some time. This trend will likely continue to intensify the competition among all sectors of medical device development.



How AI Tools Will Transform Quality Management in the Life Sciences, Part 2
by Jerry Chapman, GMP Consultant and Editor-in-chief, Xavier Health


The pharma and medical device industries are familiar with the term “continuous” — for example, continuous process verification (ICH Q8), continued process verification (U.S. Food and Drug Administration [FDA] Guidance on Process Validation), and continuous quality verification (ASTM E2537). However, the CPQA term the team uses is quite different.


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Bioelectronic Medicine: Targeting Inflammatory Disease with Electricity

How to Make Pre-Sub Program Communication With the FDA More Transparent
by Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting


Are you getting closer to submitting a medical device for successful market clearance to the U.S. Food and Drug Administration (FDA)? Communication is the essence of all regulatory challenges associated with the mire of detail and information that is required for an approved clearance for a 510(k), Investigational Device Exemption (IDE), ...



Is Supplier Quality a Fallacy? Implement Risk-Based Control in Design
by Walt Murray, MasterControl Consulting Partner and Principal Consultant of Pinpoint Consulting


I’m amazed when I’m working with a 21st century regulated business that simply wants its buyers or procurement group to do “whatever” it takes to keep the material pipeline coming. That’s very 20th century thinking!



Medtech Startups: How to Survive Cutthroat Competition
by Matthew M. Lowe, Executive Vice President, MasterControl


In the fierce arena of medtech startups, competition is intense and investor confidence is high. A recent Ernst & Young report shows that early-stage medtech firms captured 52 percent of seed funding last year and surpassed the total amount for later-stage companies, the first time it has happened in 10 years.


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