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Regulatory

The Secret to Staying Ahead of Your Competition

By Rosemarie Szostak, Ph.D., Senior Analyst, Ben Bahavar, Ph.D., Senior Analyst, Jeffery Magee, BSME, MBA, Analyst – Innovation & IP Management
Originally published August 23, 2021
This article explores the importance of a targeted approach to stay ahead of competitors, disruptive technologies, regulatory hurdles, potential customer requirements, and supply chain issues. Get the article here.

Adverse Event Reporting: Pfizer, Inc. and Moderna, Inc. vs. Johnson & Johnson

By Ryan Rix, Nerac Analyst
Originally published June 3, 2021
This article looks at how the VAERS (Vaccine Adverse Event Reporting System) tracks adverse events and post market surveillance. Read more here.

Innovations in Medical Devices – Crisis as Motivation

By Helga Weires, Nerac Analyst
Originally published May 12, 2020
The world is facing unprecedented disruption due to the COVID-19 pandemic. Regardless of industry, companies are reacting quickly, placing an emphasis on safe operations and ramping up supply of essential ingredients and materials to address the crisis, while some are successfully pivoting into a completely new product line. How prepared are you to weather this storm? Get the article here.

The Clinical Evaluation Plan: Creating a Storyboard for a Medical Device

By Minh Han, MD, FAAFP, Nerac Analyst
Originally published June 24, 2019
Avengers: Endgame is the highest grossing movie in an opening weekend and it all started with a plan and a storyboard. Marvel Cinematic Universes’ strategy can also be powerful for the Medical Device Universe as well. Read the article here.

The New Post-Market Surveillance Regulations for Europe – Part 3: Trending, Analysis and Documentation

By Robert Zott, Director of Advisory Services Development, Nerac Analyst
Originally published February 15, 2019
This article (part 3 of a 3 part series) examines trend reporting (Article 88 of the MDR), the analysis of serious incidents and field safety corrective actions (Article 89), and the technical documentation requirements for PMS (Annex III).
Read the article here.

The New Post-Market Surveillance Regulations for Europe, Part 2: Serious Incidents Get A Serious Overhaul.

By Robert Zott, Director of Advisory Services Development
Originally published November 13, 2018
This article (part 2 of an ongoing series) examines the reporting of serious incidents and field safety corrective actions described in article 87.
Read the article here.

The New Post-Market Surveillance Regulations for Europe, Part 1: What to Know and Where to Go

By Robert Zott, Director of Advisory Services Development
Originally published September 10, 2018
This article (part 1 of a 3-part series) takes a closer look at the requirements for the PMS system. Read the article 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.

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.

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.

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