Originally Published January 13, 2023
By Miriam Sharif Murray, M.S.
This article explores the different types of published literature that can support Class III Medical Device submissions for FDA compliance. Get the article here.
The Use of Published Literature in FDA Medical Device Submissions
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.
The European In Vitro Diagnostic Regulation: Performance Evaluation
By Erica Kramer, Ph.D., Senior Nerac Analyst/Medical Writer
Originally published June 30, 2020
This article explores clinical evidence, performance evaluation and the resulting challenges to manufacturers, and offers guidance on how to navigate them with success. 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.
From Hal to Wall-E: Artificial Intelligence is transforming the medical device industry
By Rosemarie Szostak, Ph.D., Nerac Analyst
Originally published November 13, 2018
The holy grail of AI in healthcare is in improving patient outcomes and reducing healthcare costs. However, the primary stumbling block for AI in medical devices has been the FDA.
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.
Established and Emerging Applications of 3D Printing in the Medical Field
By Mary Becher, Nerac Analyst
Originally published June 7, 2018
This article explores current applications of 3D printing in the medical arena as well as what’s out on the horizon. Read more here.