Articles Archives - Page 3 of 18

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.

The Critical Role of Workforce in Industry 4.0

By Ben Bahavar, Ph.D., Nerac Analyst
Originally published November 14, 2017
This article takes a look at Industry 4.0, the Industrial Internet of Things (IIoT), eTransformation, or Digital Transformation, the terminology nowadays used interchangeably to describe the fourth era of industrial revolution. Read more here.