Regulatory

Similar Devices in State of the Art

Originally Published May 4, 2023
By Priscilla S. Monarca, M.P.H.

This article defines similar devices and best practices for similar device data included in state of the art evaluations and CERs under EU regulations. Get the article here.

Best Practices for the State of the Art Evaluation

Originally Published April 20, 2023
By Priscilla S. Monarca, M.P.H.

This article outlines best practices for creating the state of the art evaluation under EU regulations. Get the article here.

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
Updated May 1, 2023
In the wake of the COVID-19 pandemic, the world continues to recover from disruptions in supply chain. For many manufacturers and suppliers, a shift in the business landscape depends on looking at adjacent markets, new supply chain sources and embracing new ways of thinking and manufacturing processes that maximize chances of success, not just survival. How prepared are you to weather a 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.