Articles Archives - Page 3 of 18

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.

The European In Vitro Diagnostic Regulation: It’s Time to Start Preparing

By Erica Kramer, Ph.D., Nerac Analyst
Originally published November 14, 2017
This article explores the EU In Vitro Diagnostic regulations and the changes manufacturers face. Read more here.

Business, Butterflies, and the “Amazon Effect”

By Rosemarie Szostak, Ph.D., Nerac Analyst
Originally published September 26, 2017
This article explores how Amazon is changing how the world does business. Read more here.

Biosimilar “Patent Dance”

By Eden Joy Pacsial-Ong, Ph.D., Nerac Analyst/Patent Agent
Originally published September 26, 2017
This article explores the Biologics Price Competition and Innovations Act (BPCIA), a specific Supreme Court ruling and potential ramifications on the biologics industry. Read more here.