By Skye McClain, Ph.D.
Originally published March 27, 2018
This article explores the patent landscape in more detail, and looks at how the information gleaned from the analysis of a patent landscape can provide a company important insights to better understand their place in a given market space and help to make strategic decisions. Read more here.
Without Clinical Data, European Compliance Can Appear Unattainable
By Robert Zott, Director of Advisory Services Development
Originally published March 27, 2018
This article helps identify the specific clauses of the guidance document that pertain to clinical data and explores alternative pathways to compliance. Read more here.
Synthetic Biology: A disruptive technology on the horizon
By Rosemarie Szostak, Ph.D.
Originally published March 7, 2018
This article provides a snapshot of the synthetic biology market in a number of key industries and explores how disruptive technologies can significantly alter the way businesses operate across any market space. Read more here.
EU MDR Timeline
Originally published March 6, 2018
When it comes to the new European Medical Device Regulation (MDR), it’s critical to know where you stand. Take a look at the MDR timeline here.
Nerac Announces the February Issue of the Nerac Strategist
Originally published February 13, 2018
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Beware of Paper Devices: How Clinical Evaluations Can Be a House of Cards
By Robert Zott
Originally published February 7, 2018
This article explores potential pitfalls now faced by device manufacturers regarding CERs and offers guidance on how to navigate these with success. Read more here.
Wine Bottles, Wine Boxes and the Premium Glass of Wine: A Packaging Conundrum
By Rosemarie Szostak, Ph.D.
Originally published February 6, 2018
This article explores alternative packaging for wine that can protect and accelerate business growth. Read more here.
The Real Value of Competitive Landscape Analysis
By Kevin Closson, M.S., MBA
Originally published February 6, 2018
This article describes the inherent value of conducting a CLA and why they are worth exploring in more detail. Read more here.
Full Speed Ahead: Navigating the New European Medical Device Regulation
By Robert Zott, Director of Advisory Services
Originally published July 18, 2018
This article takes a look at how the sweeping changes to the new European Medical Device Regulation will impact manufacturers, regulators and auditing bodies.
Read more here.
Internet of Things
By Thomas A. Perkins, Nerac Analyst
Originally published November 14, 2017
This article explores the Internet of Things (IoT). Read more here.
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